Atlas FDA

GGN

99 FDA 510(k) clearances · Product code

75 daysmedian time to decision
298 days90th percentile
99clearances measured

FDA profile

Official device name
Plasma, Coagulation Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Medical specialty
Hematology
Adverse events (MAUDE)
2011: 30 · 2012: 10 · 2013: 9 · 2015: 10 · 2016: 9 · 2017: 11
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
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (K170864)Maine Standards Company, LLC2017-06-21
VALIDATE Heparin Calibration Verification/Linearity Test Kit (K163498)Maine Standards Company, LLC2017-03-16
George King Coumadin Plasma (K161316)George King Bio-Medical, Inc.2017-02-23
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (K162705)Maine Standards Company, LLC2017-01-05
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (K152961)Maine Standards Company, LLC2016-06-03
VisuCon-F Low Fibrinogen Control Plasma (K150144)Affinity Biologicals, Inc.2016-03-06
POOL NORM (K142132)Diagnostics Stago S.A.S.2014-12-12
HEMOSIL D-DIMER HS 500 CONTROL (K133582)Instrumentation Laboratory2014-08-15
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC (K120977)International Technidyne Corp.2013-07-03
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (K120900)Cliniqa Corporation2013-05-31
STA- COAG CONTROL (N+ABN) PLUS (K120014)Diagnostica Stago, Inc.2013-03-14
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL (K113211)Instrumentation Laboratory CO2012-01-04
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN (K110432)Affinity Biologicals, Inc.2011-10-20
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 (K100716)Aalto Scientific, Ltd.2011-06-23
PT-MULTI-CALIBRATOR, MODEL OPAT07 (K093848)Dade Behring, Inc.2010-12-20
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL (K103314)Medtronic, Inc.2010-12-03
HEPARIN ASSAY CONTROLS (K103313)Medtronic, Inc.2010-12-01
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA (K091284)Affinity Biologicals, Inc.2009-10-28
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) (K090563)Instrumentation Laboratory CO2009-10-09
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED (K082859)Instrumentation Laboratory CO2008-12-19
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 (K071319)Bio-Rad, Diagnostics Grp.2007-06-26
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (K062840)Biosite Incorporated2007-03-01
COAGUCHEK XS PT CONTROLS (K063823)Roche Diagnostics Corp.2007-01-29
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL (K052697)Akers Biosciences, Inc.2006-01-04
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR (K051472)Hyphen Biomed2005-12-23
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS (K050799)Biosite Incorporated2005-06-29
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR (K043451)Hyphen Biomed2005-03-17
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS (K042760)Pentapharm , Ltd.2004-12-22
CONTROL PLASMA N, PROC CONTROL PLASMA (K042333)Dade Behring, Inc.2004-12-01
CONTROL PLASMA N AND CONTROL PLASMA P (K042209)Dade Behring, Inc.2004-10-21
PURPLE/BLACK HEPARIN ASSAY CONTROL (K042206)Medtronic Vascular2004-10-18
HEPARINASE HR ACT CONTROL, MODEL 550-12 (K042175)Medtronic Vascular2004-10-18
LYPHOCHEK HEMOSTASIS CONTROL (K040275)Bio-Rad2004-02-27
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 (K032611)Bio-Rad2003-09-17
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 (K032017)Bio-Rad2003-08-08
CONTROL PLASMA LMW HEPARIN (K030965)Instrumentation Laboratory CO2003-06-06
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 (K030182)Bio-Rad2003-02-24
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL (K022046)Vital Scientific N.V.2002-07-23
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED (K021024)Instrumentation Laboratory CO2002-05-16
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) (K021023)Instrumentation Laboratory CO2002-05-14
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) (K021022)Instrumentation Laboratory CO2002-05-14
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 (K012722)Bio-Rad2001-09-18
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (K010750)Fisher Diagnostics2001-09-07
STA -CALIBRATOR HBPM/LMWH KIT (K010350)Diagnostica Stago, Inc.2001-04-09
STA-QUALITY HBPM/LMWH KIT (K010324)Diagnostica Stago, Inc.2001-04-09
THROMBOSTRATE CONTROL PLASMAS (K000679)Pacific Hemostasis2000-03-24
HMP CONTROLS (TAS) RAPIDPOINT (K994159)Cardiovascular Diagnostics, Inc.2000-02-15
POLLER CALIBRANTS (K991439)European Concerted Action on Anticoagulation1999-12-20
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 (K992829)Medical Analysis Systems, Inc.1999-11-22
HEPARIN CONTROL PLASMA LEVEL 2 (K992279)Pacific Hemostasis1999-08-26
HEPARIN CONTROL PLASMA LEVEL 1 (K992278)Pacific Hemostasis1999-08-26
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 (K990858)Bio-Rad1999-04-21
I-STAT COAGULATION CONTROL SET (K981752)Biopool Intl., Inc.1998-06-15
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I (K981248)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III (K981255)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II (K981254)Sigma Diagnostics, Inc.1998-04-29
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS (K981178)Cardiovascular Diagnostics, Inc.1998-04-27
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 (K980982)Avocet Medical, Inc.1998-04-16
CRYO CHECK INR VALIDATION SET (K971219)Precision Biologicals, Inc.1997-08-29
CRYO CHECK APC RESISTANT PLASMA (K971222)Precision Biologicals, Inc.1997-08-19
STA LIATEST CONTROL [N]+[P] KIT (K964716)American Bioproducts Co.1997-06-26
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 (K971428)Pacific Hemostasis1997-06-17
TAS PT-NCTEST CONTROLS (K971748)Cardiovascular Diagnostics, Inc.1997-05-29
LYPHOCHEK COAGULATION CONTROL (K964963)Bio-Rad1997-02-20
STA - VWF CONTROL [N]+[P] KIT (K962674)American Bioproducts Co.1996-07-23
TAS A PTT TEST CONTROLS (K961189)Cardiovascular Diagnostics, Inc.1996-06-05
TAS HMT CONTROLS (K960234)Cardiovascular Diagnostics, Inc.1996-05-30
BEHRING COAGULATION TIMER (K955278)Behring Diagnostics, Inc.1996-05-30
PORCINE FACTOR VIII;C REAGENT (K952321)Helena Laboratories1996-03-11
CRYO CHECK LOW FIBRINOGEN CONTROL (K951823)Precision Biologicals, Inc.1996-01-03
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA (K952622)Precision Biologicals, Inc.1995-10-30
B-FACT, BORDERLINE FACTOR ASSAY CONTROL (K945854)George King Bio-Medical, Inc.1995-10-24
A-FACT, ABNORMAL FACTOR ASSAY CONTROL (K945855)George King Bio-Medical, Inc.1995-10-24
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL (K940209)Ortho Diagnostic Systems, Inc.1995-05-11
STA SYSTEM CONTROL [N] + [P] KIT (K943518)American Bioproducts Co.1995-03-21
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II (K944691)International Technidyne Corp.1995-03-15
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) (K941860)Helena Laboratories1994-09-14
COAGULATION A.R.P. (K933277)Helena Laboratories1994-03-22
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM (K922887)Precision Biologicals, Inc.1993-02-25
CLIBRATION PLASMAS (K924404)Behring Diagnostics, Inc.1992-12-01
COAG-CONTROL [N] KIT (K922174)American Bioproducts Co.1992-10-26
THROMBO-CALIBRATOR KIT (K921344)American Bioproducts Co.1992-06-09
COAGULATION ARPR,CAT.NO.5185 (K914949)Helena Laboratories1992-03-04
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED (K911777)Helena Laboratories1991-08-22
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 (K905673)Helena Laboratories1991-02-11
COAGULATION CONTROL, LEVEL III (K902363)Sigma Chemical Co.1990-07-26
COAGULATION CONTROL, LEVEL II (K902362)Sigma Chemical Co.1990-07-26
COAGULATION CONTROL, LEVEL I (K902361)Sigma Chemical Co.1990-07-26
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA (K902210)Ortho Diagnostic Systems, Inc.1990-07-03
ROCKET REFERENCE PLASMA, CAT NO. 5188 (K900019)Helena Laboratories1990-01-25
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO (K884901)Baxter Healthcare Corp1989-02-02
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) (K884854)Precision Biologicals, Inc.1989-01-30
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II (K882480)International Technidyne Corp.1988-08-30
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II (K882481)International Technidyne Corp.1988-08-30
VERIFY(R) REFERENCE PLASMA (K881348)Organon Teknika Corp.1988-05-02
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER (K880302)Hemotec, Inc.1988-02-19
DIACELIN (K840288)Diatech, Inc.1984-04-23
CONTACT-K APTT REAGENT (K834086)Pacific Hemostasis1984-02-03
CI-TROL COAGULATION CONTROLS II & III (K771346)Dade, Baxter Travenol Diagnostics, Inc.1977-08-22

Track GGN automatically

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