Atlas FDA

GGP

190 FDA 510(k) clearances · Product code

71 daysmedian time to decision
227 days90th percentile
190clearances measured

FDA profile

Official device name
Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Medical specialty
Hematology
Flags
Third-party review eligible
Sort:Newest firstOldest first

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

RecordFirmDate
CRYOcheck Chromogenic Factor VIII (K251440)Precision Biologic, Inc.2025-08-25
HemosIL Chromogenic Factor IX (K230852)Instrumentation Laboratory Company2023-12-13
vWF Ag (K220728)Siemens Healthcare Diagnostics Products GmbH2023-06-02
CRYOcheck Chromogenic Factor IX (K214002)Precision Biologic, Inc.2022-12-23
HemosIL von Willebrand Factor Antigen (K223402)Instrumentation Laboratory CO2022-12-09
HemosIL von Willebrand Factor Antigen (K200033)Instrumentation Laboratory CO2020-08-19
Cryocheck Chromogenic Factor VIII (K193204)Precision Biologic2020-07-17
CRYOcheck FVIII Inhibitor Kit (K183440)Precision Biologic, Inc.2019-03-12
INNOVANCE Free PS Ag (K181525)Siemens Healthcare Diagnostics Products GmbH2018-09-07
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (K133005)Instrumentation Laboratory CO2014-03-13
HEMOSIL PROTEIN S ACTIVITY ASSAY (K102164)Instrumentation Laboratory CO2011-03-17
STA LIATEST FREE PS (K092170)Diagnostica Stago, Inc.2009-12-22
THROMBO TEK PSE, MODEL 90-480 (K082631)R2 Diagnostics, Inc.2008-12-17
FACTOR VIII ANTIBODY SCREEN (K082205)Genetic Testing Institute2008-11-20
SPECTROLYSE PAI-1, MODEL 101201 (K063323)American Diagnostica, Inc.2007-08-15
HEMOSIL PROCLOT (K070635)Instrumentation Laboratory CO2007-03-29
TRIAGE PROTEIN C TEST (K062530)Biosite Incorporated2007-01-29
HEMOSIL PROTEIN C (K062430)Instrumentation Laboratory CO2006-09-01
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG (K052825)Affinity Biologicals, Inc.2006-01-20
HEMOSIL PROS (K053499)Instrumentation Laboratory CO2006-01-13
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (K050365)Hyphen Biomed2005-12-27
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 (K050448)Horiba Abx2005-09-23
VISULIZE FACTOR IX ANTIGEN KIT (K051054)Affinity Biologicals, Inc.2005-06-29
CRYOCHECK CLOT S (K043571)Precision Biologic, Inc.2005-03-18
COATEST SP FVIII (K042576)Instrumentation Laboratory CO2004-12-02
CRYOCHECK CLOT C (K040987)Precision Biologic, Inc.2004-06-18
HEMOSIL VON WILLEBRAND ACTIVITY (K040843)Instrumentation Laboratory CO2004-04-30
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 (K032139)Corgenix, Inc.2004-04-05
MODIFICATION TO COATEST FACTOR VIII (K033631)Instrumentation Laboratory CO2003-12-15
CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 (K023990)Precision Biologic2003-03-19
PROTEIN S AC (K022290)Dade Behring, Inc.2002-08-27
IMUBIND TPA ELISA, MODEL 860 (K013492)American Diagnostica, Inc.2002-03-13
IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (K013168)American Diagnostica, Inc.2002-03-07
ACTICLOT PROTEIN S, MODEL 843L (K012386)American Diagnostica, Inc.2001-09-14
IL TEST PROS (K011424)Instrumentation Laboratory CO2001-06-25
STA-LIATEST FREE PROTEIN S TEST KIT (K010963)Diagnostica Stago, Inc.2001-06-06
IL TEST FREE PROTEIN S (K010379)Instrumentation Laboratory CO2001-04-13
COALIZA PROTEIN S-FREE (K002467)Instrumentation Laboratory CO2000-10-13
REFACTO LABORATORY STANDARD (K002350)The Genetics Institute2000-10-05
PROTEIN C REAGENT (K002541)Dade Behring, Inc.2000-09-26
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K000649)Dade Behring, Inc.2000-04-25
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (K000398)Shield Diagnostics, Ltd.2000-04-17
GTI-FVIII INHIBITOR ASSAY (K993553)Genetic Testing Institute2000-02-01
IL TEST VON WILLEBRAND FACTOR (K992704)Instrumentation Laboratory CO1999-11-01
BIOCLOT APC SENSITIVITY (K983898)Biopool Intl., Inc.1999-01-06
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT (K983914)Corgenix, Inc.1998-12-22
VFE (K983107)Ramco Laboratories, Inc.1998-10-22
COAMATIC PLASMIN INHIBITOR (K981817)Instrumentation Laboratory CO1998-09-28
IL TEST PLASMIN INHIBITOR (K981696)Instrumentation Laboratory CO1998-08-27
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (K980885)Shield Diagnostics, Ltd.1998-08-21
IL TEST PLASMINOGEN (K981200)Instrumentation Laboratory CO1998-05-26
COAMATIC PLASMINOGEN (K974711)Instrumentation Laboratory CO1998-05-01
IL TEST PROTEIN C (K980875)Instrumentation Laboratory CO1998-04-21
COAMATIC FACTOR VIII (K981038)Instrumentation Laboratory CO1998-04-16
N-ASSAY TIA PLASMINOGEN TEST KIT (K971985)Crestat Diagnostics, Inc.1997-10-20
REAADS PROTEIN C ANTIGEN TEST KIT (K972342)Reaads Medical Products, Inc.1997-10-06
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA (K973143)Universal Reagents, Inc.1997-09-25
ASSERACHROM TPA TEST KIT (K971519)American Bioproducts Co.1997-08-19
REAADS PROTEIN S ANTIGEN TEST KIT (K972482)Reaads Medical Products, Inc.1997-08-13
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT (K972005)Reaads Medical Products, Inc.1997-08-13
VON WILLEBRAND REAGENT (K972116)Behring Diagnostics, Inc.1997-07-25
FACTOR DEFICIENT PLASMAS - FACTOR IX (9) (K972288)Universal Reagents, Inc.1997-07-14
HUMAN PROTEIN S RID TEST KIT (K951640)The Binding Site, Ltd.1997-04-21
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA (K964459)Universal Reagents, Inc.1996-12-18
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA (K964270)Universal Reagents, Inc.1996-12-18
PROC APC ASSAY, PROC CONTROL PLASMA (K962968)Behring Diagnostics, Inc.1996-12-13
CHROMOLIZE PAI-1 KIT (K963106)Medical Diagnostic Technologies, Inc.1996-11-18
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (K962825)Shield Diagnostics, Ltd.1996-11-15
FACTOR DEFICIENT PLASMA (K961929)Universal Reagents, Inc.1996-10-10
CHROMOLIZE TPA ASSAY KIT (K962489)Medical Diagnostic Technologies, Inc.1996-07-31
TINTELIZE PAI-1 KIT (K960438)Medical Diagnostic Technologies, Inc.1996-06-05
BIOCLOT PROTEIN S (K955738)Medical Diagnostic Technologies, Inc.1996-02-29
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II (K952126)Aalto Scientific, Ltd.1996-02-29
CHROM Z-F:VIII, CAT. NO. 5241 (K952668)Helena Laboratories1996-02-09
CHROM Z-PROTEIN C, CAT. NO. 5243 (K952666)Helena Laboratories1996-01-30
CHROM Z-PLASMINOGEN, CAT. NO. 5244 (K952669)Helena Laboratories1995-12-07
ASSERACHROM TOTAL PROTEIN S KIT (K954040)American Bioproducts Co.1995-11-13
ASSERACHROM FREE PROTEIN S KIT (K954017)American Bioproducts Co.1995-11-13
COAMATIC FACTOR VIII (K943225)Pharmacia Hepar, Inc.1995-11-06
SPECTROLYSE ANTIPLASMIN KIT (K941752)Biopool AB1995-09-25
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES (K942087)Biopool AB1995-07-13
HUMAN PROTEIN C RID TEST KIT (K950015)Jay H. Geller1995-03-06
PROTEIN C REAGENT, COAGULOMETRIC (K924425)Behring Diagnostics, Inc.1995-01-24
RISTOCETIN COFACTOR ASSAY KIT (K945414)Chrono-Log Corp.1995-01-11
HEMOLAB PROTEIN C CHROMOGENIC ASSAY (K934210)Biomerieux Vitek, Inc.1994-12-22
TINTELIZER(R) TPA (K934314)Biopool AB1994-02-23
MDA PROTEIN ASSAY (K925617)Organon Teknika Corp.1994-01-27
SPECTROLYSE FACTOR VII:C (K934584)Meditech, Inc.1993-12-06
NEW STACHROM PROTEIN C TEST KIT (K931906)American Bioproducts Co.1993-11-05
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY (K930235)Technidyne Corp.1993-09-02
IL TEST(TM) PROTEIN S (K930327)Instrumentation Laboratory CO1993-04-12
IL TEST(TM) PRO-CHROM (K924884)Instrumentation Laboratory CO1993-01-14
COAMATE PROTEIN C CHROMOGENIC ASSAY (K922201)Chromogenix AB1992-12-07
SPECTROLYSE/PL PAI KIT (K922782)Biopool AB1992-10-09
NEW STACHROM ANTIPLASMIN (K921449)American Bioproducts Co.1992-09-23
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM (K920012)Instrumentation Laboratory CO1992-08-12
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA (K920981)Medical Diagnostic Technologies, Inc.1992-04-17
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY (K914818)Baxter Diagnostics, Inc.1992-01-15
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES (K915163)Biopool AB1992-01-06
SPECTROLYSE PROTEIN C KIT (K914307)Biopool AB1991-12-09
Next →

Track GGP automatically

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