GGW · Class II · 21 CFR 864.7925

FDA Product Code GGW: Test, Time, Partial Thromboplastin

Leading manufacturers include American Bioproducts Co., Bio/Data Corp. and Helena Laboratories.

32
Total
32
Cleared
117d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 30d recently vs 119d historically

FDA 510(k) Cleared Test, Time, Partial Thromboplastin Devices (Product Code GGW)

32 devices
1–24 of 32
Cleared Mar 20, 2026
HemosIL Factor V Leiden (APC Resistance V)
K260551
Instrumentation Laboratory (IL) Co.
Hematology · 30d
Cleared Mar 21, 1995
PTT-LT TEST KIT
K941210
American Bioproducts Co.
Hematology · 372d
Cleared Aug 09, 1993
STACLOT(R) PNP TEST KIT
K924370
American Bioproducts Co.
Hematology · 346d
Cleared Jun 09, 1992
PTT-LA TEST KIT
K921684
American Bioproducts Co.
Hematology · 62d
Cleared Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Aug 14, 1990
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
K902236
Biosearch Medical Products, Inc.
Immunology · 89d
Cleared Nov 20, 1987
PLATELET EXTRACT REAGENT
K873382
Bio/Data Corp.
Hematology · 88d
Cleared Oct 17, 1986
ACTIN FSL ACTIVATED PTT REAGENT
K863594
American Dade
Hematology · 32d
Cleared Jun 23, 1986
PTT AUTOMATE TEST KIT
K861190
American Bioproducts Co.
Hematology · 84d
Cleared Oct 10, 1985
CITREX H
K853897
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CEPHALINEX ACTIVATED PTT REAGENT
K852195
Bio/Data Corp.
Hematology · 84d
Cleared May 29, 1985
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 71d
Cleared Apr 05, 1983
ACTIVAT-PARTIAL THROMBO-PLASTIN
K830320
Helena Laboratories
Hematology · 64d
Cleared Oct 08, 1982
ACUSCREEN
K822782
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
K811589
American Dade
Hematology · 38d
Cleared Nov 12, 1980
AB-TROL COAGULATION CONTROL
K802232
Helena Laboratories
Hematology · 58d
Cleared Sep 09, 1980
HEP-TROL
K801932
Helena Laboratories
Hematology · 28d
Cleared Jul 21, 1980
VERIFY S PROD. #34141
K800925
General Diagnostics
Hematology · 91d
Cleared Jul 14, 1980
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K800787
Electro-Nucleonics Laboratories, Inc.
Microbiology · 97d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725
Abbott Laboratories
Hematology · 64d
Cleared Nov 05, 1979
LANCER COAGENT APTT KIT
K792048
Sherwood Medical Co.
Hematology · 24d

About Product Code GGW - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code GGW since 1979, with 32 receiving FDA clearance (average review time: 117 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GGW Product Code

Recent submissions under GGW have taken an average of 30 days to reach a decision - down from 119 days historically, suggesting improved FDA processing for this classification.

GGW devices are reviewed by the Hematology panel. Browse all Hematology devices →