Product code GGP— Hematology
COAMATIC FACTOR VIII
- Classification name
- Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Total cleared
- 190
- First cleared
- Most recent
Market context for product code GGP
FDA has cleared devices under product code GGP between 1977 and 2025, filed by 54 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- 2025
- 2023
- 2022
- 2020
- 2019
- 2018
- 2014
- 2011
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code GGP
Recent clearances under product code GGP
1–100 of 190- K251440 — CRYOcheck Chromogenic Factor VIII
- K230852 — HemosIL Chromogenic Factor IX
- K220728 — vWF Ag
- K214002 — CRYOcheck Chromogenic Factor IX
- K223402 — HemosIL von Willebrand Factor Antigen
- K200033 — HemosIL von Willebrand Factor Antigen
- K193204 — Cryocheck Chromogenic Factor VIII
- K183440 — CRYOcheck FVIII Inhibitor Kit
- K181525 — INNOVANCE Free PS Ag
- K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
- K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY
- K092170 — STA LIATEST FREE PS
- K082631 — THROMBO TEK PSE, MODEL 90-480
- K082205 — FACTOR VIII ANTIBODY SCREEN
- K063323 — SPECTROLYSE PAI-1, MODEL 101201
- K070635 — HEMOSIL PROCLOT
- K062530 — TRIAGE PROTEIN C TEST
- K062430 — HEMOSIL PROTEIN C
- K052825 — VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
- K053499 — HEMOSIL PROS
- K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
- K050448 — CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
- K051054 — VISULIZE FACTOR IX ANTIGEN KIT
- K043571 — CRYOCHECK CLOT S
- K042576 — COATEST SP FVIII
- K040987 — CRYOCHECK CLOT C
- K040843 — HEMOSIL VON WILLEBRAND ACTIVITY
- K032139 — REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
- K033631 — MODIFICATION TO COATEST FACTOR VIII
- K023990 — CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
- K022290 — PROTEIN S AC
- K013492 — IMUBIND TPA ELISA, MODEL 860
- K013168 — IMUBIND PLASMA PAI-1 ELISA,MODEL 822
- K012386 — ACTICLOT PROTEIN S, MODEL 843L
- K011424 — IL TEST PROS
- K010963 — STA-LIATEST FREE PROTEIN S TEST KIT
- K010379 — IL TEST FREE PROTEIN S
- K002467 — COALIZA PROTEIN S-FREE
- K002350 — REFACTO LABORATORY STANDARD
- K002541 — PROTEIN C REAGENT
- K000649 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
- K993553 — GTI-FVIII INHIBITOR ASSAY
- K992704 — IL TEST VON WILLEBRAND FACTOR
- K983898 — BIOCLOT APC SENSITIVITY
- K983914 — REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
- K983107 — VFE
- K981817 — COAMATIC PLASMIN INHIBITOR
- K981696 — IL TEST PLASMIN INHIBITOR
- K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
- K981200 — IL TEST PLASMINOGEN
- K974711 — COAMATIC PLASMINOGEN
- K980875 — IL TEST PROTEIN C
- K981038 — COAMATIC FACTOR VIII
- K971985 — N-ASSAY TIA PLASMINOGEN TEST KIT
- K972342 — REAADS PROTEIN C ANTIGEN TEST KIT
- K973143 — UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
- K971519 — ASSERACHROM TPA TEST KIT
- K972005 — REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
- K972482 — REAADS PROTEIN S ANTIGEN TEST KIT
- K972116 — VON WILLEBRAND REAGENT
- K972288 — FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
- K951640 — HUMAN PROTEIN S RID TEST KIT
- K964270 — UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
- K964459 — UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
- K962968 — PROC APC ASSAY, PROC CONTROL PLASMA
- K963106 — CHROMOLIZE PAI-1 KIT
- K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
- K961929 — FACTOR DEFICIENT PLASMA
- K962489 — CHROMOLIZE TPA ASSAY KIT
- K960438 — TINTELIZE PAI-1 KIT
- K952126 — AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
- K955738 — BIOCLOT PROTEIN S
- K952668 — CHROM Z-F:VIII, CAT. NO. 5241
- K952666 — CHROM Z-PROTEIN C, CAT. NO. 5243
- K952669 — CHROM Z-PLASMINOGEN, CAT. NO. 5244
- K954017 — ASSERACHROM FREE PROTEIN S KIT
- K954040 — ASSERACHROM TOTAL PROTEIN S KIT
- K943225 — COAMATIC FACTOR VIII
- K941752 — SPECTROLYSE ANTIPLASMIN KIT
- K942087 — BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
- K950015 — HUMAN PROTEIN C RID TEST KIT
- K924425 — PROTEIN C REAGENT, COAGULOMETRIC
- K945414 — RISTOCETIN COFACTOR ASSAY KIT
- K934210 — HEMOLAB PROTEIN C CHROMOGENIC ASSAY
- K934314 — TINTELIZER(R) TPA
- K925617 — MDA PROTEIN ASSAY
- K934584 — SPECTROLYSE FACTOR VII:C
- K931906 — NEW STACHROM PROTEIN C TEST KIT
- K930235 — HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
- K930327 — IL TEST(TM) PROTEIN S
- K924884 — IL TEST(TM) PRO-CHROM
- K922201 — COAMATE PROTEIN C CHROMOGENIC ASSAY
- K922782 — SPECTROLYSE/PL PAI KIT
- K921449 — NEW STACHROM ANTIPLASMIN
- K920012 — IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
- K920981 — RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
- K914818 — DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
- K915163 — PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
- K914307 — SPECTROLYSE PROTEIN C KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.