Atlas FDA

GGW

32 FDA 510(k) clearances · Product code

84 daysmedian time to decision
245 days90th percentile
32clearances measured

FDA profile

Official device name
Test, Time, Partial Thromboplastin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 15 · 2018: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HemosIL Factor V Leiden (APC Resistance V) (K260551)Instrumentation Laboratory (IL) Co.2026-03-20
LUPOTEK KCT (K090105)R2 Diagnostics, Inc.2010-12-30
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN (K083729)Aniara Diagnostica, LLC2009-05-08
CRYOCHECK CLOT APCR (K060284)Precision Biologic, Inc.2006-05-10
PEFAKIT APC-R FACTOR V LEIDEN (K042762)Pentapharm , Ltd.2004-12-22
PHOSPHOLIN ES AND CALCIUM CHLORIDE (K033471)R2 Diagnostics, Inc.2004-02-04
GRADILEIDEN V TEST (K992456)Gradipore , Ltd.1999-12-21
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (K982062)Precision Biologicals, Inc.1999-01-13
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (K963111)Chromogenix AB1996-12-23
COATEST(R) APC(TM) RESISTANCE (K945940)Axis-Shield Doc AS1995-08-07
PTT-LT TEST KIT (K941210)American Bioproducts Co.1995-03-21
STACLOT(R) PNP TEST KIT (K924370)American Bioproducts Co.1993-08-09
PTT-LA TEST KIT (K921684)American Bioproducts Co.1992-06-09
ACTIVATED PARTIAL THROMBOPLASTIN TIME (K915463)Sigma Diagnostics, Inc.1992-01-23
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT (K902236)Biosearch Medical Products, Inc.1990-08-14
PLATELET EXTRACT REAGENT (K873382)Bio/Data Corp.1987-11-20
ACTIN FSL ACTIVATED PTT REAGENT (K863594)American Dade1986-10-17
PTT AUTOMATE TEST KIT (K861190)American Bioproducts Co.1986-06-23
CITREX H (K853897)Bio/Data Corp.1985-10-10
CEPHALINEX ACTIVATED PTT REAGENT (K852195)Bio/Data Corp.1985-08-12
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC (K851126)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
CALCIUM CHLORIDE (K841522)Diatech, Inc.1984-04-30
ACTIVAT-PARTIAL THROMBO-PLASTIN (K830320)Helena Laboratories1983-04-05
ACUSCREEN (K822782)Ortho Diagnostic Systems, Inc.1982-10-08
ACTIN FS ACTIVATED PTT REAGENT (K811589)American Dade1981-07-16
AB-TROL COAGULATION CONTROL (K802232)Helena Laboratories1980-11-12
HEP-TROL (K801932)Helena Laboratories1980-09-09
PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT (K801460)Pacific Hemostasis1980-07-28
VERIFY S PROD. #34141 (K800925)General Diagnostics1980-07-21
ANTIBODY TO VARICELLA-ZOSTER VIRUS (K800787)Electro-Nucleonics Laboratories, Inc.1980-07-14
A-GENT QUANTICHROM THROMBIGEN I (K800725)Abbott Laboratories1980-06-04
LANCER COAGENT APTT KIT (K792048)Sherwood Medical Co.1979-11-05

Track GGW automatically

Every clearance here is in the API, with alerts when new ones post.