Product code GGC— Hematology
CONTROL PLASMA P
- Classification name
- Control, Plasma, Abnormal
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Total cleared
- 40
- First cleared
- Most recent
Market context for product code GGC
FDA has cleared devices under product code GGC between 1977 and 2011, filed by 24 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- 2011
- 2010
- 2007
- 2006
- 2003
- 2002
- 2001
- 2000
- 1998
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
Top applicants under product code GGC
Recent clearances under product code GGC
- K102552 — HEMOSIL LA POSITIVE CONTROL
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2
- K061803 — STA - CONTROL LA 1+2
- K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL
- K023312 — CONTROL PLASMA P
- K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799
- K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
- K012422 — K-ASSAY D-DIMER CONTROLS
- K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
- K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
- K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL)
- K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL)
- K961370 — LA POSITIVE CONTROL PLASMA
- K955040 — AT-III CONTROL PLASMA KIT
- K952623 — CRYO CHECK LUPUS PLASMA
- K952624 — CRYO CHECK ABNORMAL REFERENCE CHECK I & II
- K945856 — POSITIVE LUPUS ANTICOAGULANT PLASMA
- K952338 — STA-COAG CONTROL [P] PLUS KIT
- K941872 — SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
- K930267 — BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
- K924401 — PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
- K924402 — CONTROL PLASMA U
- K930959 — FACTOR CONTROL [P]
- K930923 — COAG-CONTROL
- K924405 — CONTROL PLASMA P
- K921665 — AVK CONTROL I & II
- K911885 — DADE(R) PROTEIN C ABNORMAL CONTRAL
- K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL
- K901233 — ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
- K900782 — HEPARIN CONTROL PLASMA, FOR USE IN APTT
- K895260 — ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
- K895261 — ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
- K894425 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
- K893970 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
- K893971 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
- K894338 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
- K881510 — CLP ABNORMAL COAGULATION CONTROL
- K871420 — HERPES 1 AND 2 MICROASSAYS
- K770188 — HPC TM (HEPARINIZED PLASMA CONTROL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.