Atlas FDA

GFO

52 FDA 510(k) clearances · Product code

79 daysmedian time to decision
181 days90th percentile
52clearances measured

FDA profile

Official device name
Activated Partial Thromboplastin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 2 · 1997: 1 · 1998: 8 · 1999: 1 · 2011: 7 · 2017: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HemosIL Silica Clotting Time (K253957)Instrumentation Laboratory (IL) Co.2026-01-09
Cryocheck Hex LA (K193556)Precision Biologic2020-10-23
HemosIL Silica Clotting Time (K160445)Instrumentation Laboratory CO2016-03-16
STA-CEPHASCREEN KIT (K053111)Diagnostica Stago, Inc.2006-05-04
HEMOSIL SYNTHASIL (K060688)Instrumentation Laboratory CO2006-04-13
HEMOSIL SILICA CLOTTING TIME (K050221)Instrumentation Laboratory CO2005-03-30
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (K022021)Vital Scientific N.V.2002-11-01
CARESIDE APTT (K014028)Careside Hemotology, Inc.2002-02-08
HEMOCHRON JR. CITRATE APTT CUVETTE (K014008)Itc, Inc.2002-01-24
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712)Sigma Diagnostics, Inc.1999-12-06
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711)Sigma Diagnostics, Inc.1999-12-06
HEMOCHRON CITRATE APTT (K972831)International Technidyne Corp.1997-11-20
IL TEST APTT-SP (K973306)Instrumentation Laboratory CO1997-11-04
SPECKTIN-LA TEST SET (K961892)Analytical Control Systems, Inc.1997-03-07
SYNTHAFAX APTT REAGENT (K955638)Ortho Diagnostic Systems, Inc.1996-04-23
PATHROMTIN SL (K955450)Behring Diagnostics, Inc.1996-04-19
SYNTHASIL APTT REAGENT (K953981)Ortho Diagnostic Systems, Inc.1995-11-30
APTT-ES (K935169)Helena Laboratories1994-12-02
APTT-ES REAGENT (K934351)Medical Diagnostic Technologies, Inc.1993-12-06
PATHROMTIN (K932011)Behring Diagnostics, Inc.1993-10-25
ACS APCT REAGENT, MODIFIED (K926012)Analytical Control Systems, Inc.1993-04-27
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT (K924637)International Technidyne Corp.1993-01-27
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT (K924638)International Technidyne Corp.1993-01-14
STACLOT LA TEST KIT (K923731)American Bioproducts Co.1992-12-23
PLATELIN L (K921396)Organon Teknika Corp.1992-10-19
ACS FREEZE-DRIED APTT REAGENT (K921223)Analytical Control Systems, Inc.1992-08-18
ACS APCT REAGENT (K921118)Analytical Control Systems, Inc.1992-07-28
ELLAGIC ACID APTT REAGENT (K915418)Helena Laboratories1992-02-14
HEMOCHRON ONESTEP APTT TEST (K915344)International Technidyne Corp.1992-02-11
HEMOCHRON(R) APTT, MODIFICATION (K911994)International Technidyne Corp.1991-07-17
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (K903531)Medical Innovations Corp.1991-01-25
THE THERATEST ACA TEST (K905301)Theratest Laboratories, Inc.1991-01-14
APTT REAGENT (K904341)Sigma Chemical Co.1990-11-08
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K902556)Analytical Control Systems, Inc.1990-08-06
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT (K900049)Medical Diagnostic Technologies, Inc.1990-01-25
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) (K896545)Sigma Chemical Co.1989-12-01
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT (K895255)Medical Diagnostic Technologies, Inc.1989-10-06
APTT BY HEMOCHRON(R) (K892209)Intensive Technology, Inc.1989-06-22
COAG-1 APTT TEST CARD (K891015)Cardiovascular Diagnostic Services1989-05-22
THROMBOSCREEN APTT REAGENT (K891337)Pacific Hemostasis1989-04-21
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (K890859)Elite Diagnostic , Ltd.1989-04-21
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K890619)Elite Diagnostic , Ltd.1989-03-15
BIOTRACK APTT REAGENT CARTRIDGE (K890052)Biotrack, Inc.1989-02-24
APTT REAGENT (K884856)Precision Biologicals, Inc.1989-01-30
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 (K884702)Em Diagnostic Systems, Inc.1989-01-27
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K884485)King Diagnostics, Inc.1988-12-28
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K882325)Sclavo, Inc.1988-08-25
CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K881068)Creative Laboratory Products, Inc.1988-03-23
ALUMINA SILICA-ACTIVATED PARTIAL THROM (K820835)Hyland Therapeutic Div., Travenol Laboratories1982-04-26
PLASMA COAGULATION CONT., ABNORMAL (K781104)Ortho Diagnostics, Inc.1978-08-10
HEPARIN CONTROL PLASMA (K760918)Hyland Therapeutic Div., Travenol Laboratories1977-01-10
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT (K760318)Dade, Baxter Travenol Diagnostics, Inc.1976-08-03

Track GFO automatically

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