Product code GGW— Hematology
A-GENT QUANTICHROM THROMBIGEN I
- Classification name
- Test, Time, Partial Thromboplastin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code GGW
FDA has cleared devices under product code GGW between 1979 and 2026, filed by 23 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- 2026
- 2010
- 2009
- 2006
- 2004
- 1999
- 1996
- 1995
- 1993
- 1992
- 1990
- 1987
- 1986
- 1985
- 1984
Top applicants under product code GGW
Recent clearances under product code GGW
- K260551 — HemosIL Factor V Leiden (APC Resistance V)
- K090105 — LUPOTEK KCT
- K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
- K060284 — CRYOCHECK CLOT APCR
- K042762 — PEFAKIT APC-R FACTOR V LEIDEN
- K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE
- K992456 — GRADILEIDEN V TEST
- K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
- K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
- K945940 — COATEST(R) APC(TM) RESISTANCE
- K941210 — PTT-LT TEST KIT
- K924370 — STACLOT(R) PNP TEST KIT
- K921684 — PTT-LA TEST KIT
- K915463 — ACTIVATED PARTIAL THROMBOPLASTIN TIME
- K902236 — READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
- K873382 — PLATELET EXTRACT REAGENT
- K863594 — ACTIN FSL ACTIVATED PTT REAGENT
- K861190 — PTT AUTOMATE TEST KIT
- K853897 — CITREX H
- K852195 — CEPHALINEX ACTIVATED PTT REAGENT
- K851126 — ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
- K841522 — CALCIUM CHLORIDE
- K830320 — ACTIVAT-PARTIAL THROMBO-PLASTIN
- K822782 — ACUSCREEN
- K811589 — ACTIN FS ACTIVATED PTT REAGENT
- K802232 — AB-TROL COAGULATION CONTROL
- K801932 — HEP-TROL
- K801460 — PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
- K800925 — VERIFY S PROD. #34141
- K800787 — ANTIBODY TO VARICELLA-ZOSTER VIRUS
- K800725 — A-GENT QUANTICHROM THROMBIGEN I
- K792048 — LANCER COAGENT APTT KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.