Product code GGN— Hematology
A-FACT, ABNORMAL FACTOR ASSAY CONTROL
- Classification name
- Plasma, Coagulation Control
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Total cleared
- 99
- First cleared
- Most recent
Market context for product code GGN
FDA has cleared devices under product code GGN between 1977 and 2017, filed by 40 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code GGN
Recent clearances under product code GGN
- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K161316 — George King Coumadin Plasma
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
- K150144 — VisuCon-F Low Fibrinogen Control Plasma
- K142132 — POOL NORM
- K133582 — HEMOSIL D-DIMER HS 500 CONTROL
- K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
- K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
- K120014 — STA- COAG CONTROL (N+ABN) PLUS
- K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
- K110432 — VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
- K100716 — AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
- K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07
- K103314 — CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
- K103313 — HEPARIN ASSAY CONTROLS
- K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
- K090563 — HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K082859 — HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
- K071319 — I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
- K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
- K063823 — COAGUCHEK XS PT CONTROLS
- K052697 — HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
- K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
- K050799 — TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
- K042760 — PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
- K042333 — CONTROL PLASMA N, PROC CONTROL PLASMA
- K042209 — CONTROL PLASMA N AND CONTROL PLASMA P
- K042175 — HEPARINASE HR ACT CONTROL, MODEL 550-12
- K042206 — PURPLE/BLACK HEPARIN ASSAY CONTROL
- K040275 — LYPHOCHEK HEMOSTASIS CONTROL
- K032611 — LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
- K032017 — LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
- K030965 — CONTROL PLASMA LMW HEPARIN
- K030182 — LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
- K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
- K012722 — LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
- K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
- K010324 — STA-QUALITY HBPM/LMWH KIT
- K010350 — STA -CALIBRATOR HBPM/LMWH KIT
- K000679 — THROMBOSTRATE CONTROL PLASMAS
- K994159 — HMP CONTROLS (TAS) RAPIDPOINT
- K991439 — POLLER CALIBRANTS
- K992829 — CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
- K992278 — HEPARIN CONTROL PLASMA LEVEL 1
- K992279 — HEPARIN CONTROL PLASMA LEVEL 2
- K990858 — LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
- K981752 — I-STAT COAGULATION CONTROL SET
- K981248 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
- K981254 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
- K981255 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
- K981178 — THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
- K980982 — AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
- K971219 — CRYO CHECK INR VALIDATION SET
- K971222 — CRYO CHECK APC RESISTANT PLASMA
- K964716 — STA LIATEST CONTROL [N]+[P] KIT
- K971428 — COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
- K971748 — TAS PT-NCTEST CONTROLS
- K964963 — LYPHOCHEK COAGULATION CONTROL
- K962674 — STA - VWF CONTROL [N]+[P] KIT
- K961189 — TAS A PTT TEST CONTROLS
- K955278 — BEHRING COAGULATION TIMER
- K960234 — TAS HMT CONTROLS
- K952321 — PORCINE FACTOR VIII; C REAGENT
- K951823 — CRYO CHECK LOW FIBRINOGEN CONTROL
- K952622 — CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
- K945854 — B-FACT, BORDERLINE FACTOR ASSAY CONTROL
- K945855 — A-FACT, ABNORMAL FACTOR ASSAY CONTROL
- K940209 — ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
- K943518 — STA SYSTEM CONTROL [N] + [P] KIT
- K944691 — ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
- K941860 — SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
- K933277 — COAGULATION A.R.P.
- K922887 — CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
- K924404 — CLIBRATION PLASMAS
- K922174 — COAG-CONTROL [N] KIT
- K921344 — THROMBO-CALIBRATOR KIT
- K914949 — COAGULATION ARPR,CAT.NO.5185
- K911777 — ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
- K905673 — AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
- K902361 — COAGULATION CONTROL, LEVEL I
- K902362 — COAGULATION CONTROL, LEVEL II
- K902363 — COAGULATION CONTROL, LEVEL III
- K902210 — ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
- K900019 — ROCKET REFERENCE PLASMA, CAT NO. 5188
- K884901 — DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
- K884854 — COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
- K882480 — HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
- K882481 — HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
- K881348 — VERIFY(R) REFERENCE PLASMA
- K880302 — CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
- K840288 — DIACELIN
- K834086 — CONTACT-K APTT REAGENT
- K771346 — CI-TROL COAGULATION CONTROLS II & III
Data sourced from openFDA. This site is unofficial and independent of the FDA.