FDA Product Code
FDA Product Code GGN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5425
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test Kit | Maine Standards Company, LLC | 2017-06-21 | Traditional | PDF ↗ |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2017-03-16 | Traditional | PDF ↗ |
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | 2017-02-23 | Traditional | PDF ↗ |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2017-01-05 | Traditional | PDF ↗ |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2016-06-03 | Traditional | PDF ↗ |
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | 2016-03-06 | Traditional | PDF ↗ |
| K142132 | POOL NORM | Diagnostics Stago S.A.S. | 2014-12-12 | Traditional | PDF ↗ |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | 2014-08-15 | Traditional | PDF ↗ |
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | International Technidyne Corp. | 2013-07-03 | Traditional | PDF ↗ |
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | Cliniqa Corporation | 2013-05-31 | Traditional | PDF ↗ |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | Diagnostica Stago, Inc. | 2013-03-14 | Traditional | PDF ↗ |
| K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | Instrumentation Laboratory CO | 2012-01-04 | Traditional | PDF ↗ |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN | Affinity Biologicals, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 | Aalto Scientific, Ltd. | 2011-06-23 | Traditional | PDF ↗ |
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dade Behring, Inc. | 2010-12-20 | Traditional | PDF ↗ |
| K103314 | CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL | Medtronic, Inc. | 2010-12-03 | Special | PDF ↗ |
| K103313 | HEPARIN ASSAY CONTROLS | Medtronic, Inc. | 2010-12-01 | Special | PDF ↗ |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA | Affinity Biologicals, Inc. | 2009-10-28 | Traditional | PDF ↗ |
| K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | Instrumentation Laboratory CO | 2009-10-09 | Traditional | PDF ↗ |
| K082859 | HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED | Instrumentation Laboratory CO | 2008-12-19 | Traditional | PDF ↗ |
| K071319 | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 | Bio-Rad, Diagnostics Grp. | 2007-06-26 | Traditional | PDF ↗ |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | Biosite Incorporated | 2007-03-01 | Traditional | PDF ↗ |
| K063823 | COAGUCHEK XS PT CONTROLS | Roche Diagnostics Corp. | 2007-01-29 | Traditional | PDF ↗ |
| K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | Akers Biosciences, Inc. | 2006-01-04 | Traditional | PDF ↗ |
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | Hyphen Biomed | 2005-12-23 | Traditional | PDF ↗ |
| K050799 | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS | Biosite Incorporated | 2005-06-29 | Traditional | PDF ↗ |
| K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | Hyphen Biomed | 2005-03-17 | Abbreviated | PDF ↗ |
| K042760 | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS | Pentapharm , Ltd. | 2004-12-22 | Abbreviated | PDF ↗ |
| K042333 | CONTROL PLASMA N, PROC CONTROL PLASMA | Dade Behring, Inc. | 2004-12-01 | Traditional | PDF ↗ |
| K042209 | CONTROL PLASMA N AND CONTROL PLASMA P | Dade Behring, Inc. | 2004-10-21 | Traditional | PDF ↗ |
| K042206 | PURPLE/BLACK HEPARIN ASSAY CONTROL | Medtronic Vascular | 2004-10-18 | Special | PDF ↗ |
| K042175 | HEPARINASE HR ACT CONTROL, MODEL 550-12 | Medtronic Vascular | 2004-10-18 | Special | PDF ↗ |
| K040275 | LYPHOCHEK HEMOSTASIS CONTROL | Bio-Rad | 2004-02-27 | Traditional | PDF ↗ |
| K032611 | LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 | Bio-Rad | 2003-09-17 | Special | PDF ↗ |
| K032017 | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 | Bio-Rad | 2003-08-08 | Traditional | PDF ↗ |
| K030965 | CONTROL PLASMA LMW HEPARIN | Instrumentation Laboratory CO | 2003-06-06 | Traditional | PDF ↗ |
| K030182 | LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 | Bio-Rad | 2003-02-24 | Traditional | PDF ↗ |
| K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | Vital Scientific N.V. | 2002-07-23 | Traditional | PDF ↗ |
| K021024 | HEMOSIL HIGH ABNORMAL CONTROL ASSAYED | Instrumentation Laboratory CO | 2002-05-16 | Traditional | PDF ↗ |
| K021022 | HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) | Instrumentation Laboratory CO | 2002-05-14 | Traditional | PDF ↗ |
| K021023 | HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) | Instrumentation Laboratory CO | 2002-05-14 | Traditional | PDF ↗ |
| K012722 | LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 | Bio-Rad | 2001-09-18 | Traditional | PDF ↗ |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | Fisher Diagnostics | 2001-09-07 | Traditional | PDF ↗ |
| K010324 | STA-QUALITY HBPM/LMWH KIT | Diagnostica Stago, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K010350 | STA -CALIBRATOR HBPM/LMWH KIT | Diagnostica Stago, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K000679 | THROMBOSTRATE CONTROL PLASMAS | Pacific Hemostasis | 2000-03-24 | Traditional | PDF ↗ |
| K994159 | HMP CONTROLS (TAS) RAPIDPOINT | Cardiovascular Diagnostics, Inc. | 2000-02-15 | Traditional | PDF ↗ |
| K991439 | POLLER CALIBRANTS | European Concerted Action on Anticoagulation | 1999-12-20 | Traditional | PDF ↗ |
| K992829 | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 | Medical Analysis Systems, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K992278 | HEPARIN CONTROL PLASMA LEVEL 1 | Pacific Hemostasis | 1999-08-26 | Traditional | PDF ↗ |
| K992279 | HEPARIN CONTROL PLASMA LEVEL 2 | Pacific Hemostasis | 1999-08-26 | Traditional | PDF ↗ |
| K990858 | LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 | Bio-Rad | 1999-04-21 | Traditional | PDF ↗ |
| K981752 | I-STAT COAGULATION CONTROL SET | Biopool Intl., Inc. | 1998-06-15 | Traditional | PDF ↗ |
| K981248 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL I | Sigma Diagnostics, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K981254 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL II | Sigma Diagnostics, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K981255 | SIGMA DIAGNOSTICS ACCUCLOT CONTROL III | Sigma Diagnostics, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K980982 | AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 | Avocet Medical, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K971219 | CRYO CHECK INR VALIDATION SET | Precision Biologicals, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K971222 | CRYO CHECK APC RESISTANT PLASMA | Precision Biologicals, Inc. | 1997-08-19 | Traditional | PDF ↗ |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | American Bioproducts Co. | 1997-06-26 | Traditional | PDF ↗ |
| K971428 | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 | Pacific Hemostasis | 1997-06-17 | Traditional | PDF ↗ |
| K971748 | TAS PT-NCTEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K964963 | LYPHOCHEK COAGULATION CONTROL | Bio-Rad | 1997-02-20 | Traditional | PDF ↗ |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | American Bioproducts Co. | 1996-07-23 | Traditional | PDF ↗ |
| K961189 | TAS A PTT TEST CONTROLS | Cardiovascular Diagnostics, Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K955278 | BEHRING COAGULATION TIMER | Behring Diagnostics, Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K960234 | TAS HMT CONTROLS | Cardiovascular Diagnostics, Inc. | 1996-05-30 | Traditional | PDF ↗ |
| K952321 | PORCINE FACTOR VIII;C REAGENT | Helena Laboratories | 1996-03-11 | Traditional | PDF ↗ |
| K951823 | CRYO CHECK LOW FIBRINOGEN CONTROL | Precision Biologicals, Inc. | 1996-01-03 | Traditional | PDF ↗ |
| K952622 | CRYO CHECK NORMAL HUMAN REFERENCE PLASMA | Precision Biologicals, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL | George King Bio-Medical, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL | George King Bio-Medical, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL | Ortho Diagnostic Systems, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K943518 | STA SYSTEM CONTROL [N] + [P] KIT | American Bioproducts Co. | 1995-03-21 | Traditional | PDF ↗ |
| K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | International Technidyne Corp. | 1995-03-15 | Traditional | PDF ↗ |
| K941860 | SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) | Helena Laboratories | 1994-09-14 | Traditional | PDF ↗ |
| K933277 | COAGULATION A.R.P. | Helena Laboratories | 1994-03-22 | Traditional | PDF ↗ |
| K922887 | CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM | Precision Biologicals, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K924404 | CLIBRATION PLASMAS | Behring Diagnostics, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K922174 | COAG-CONTROL [N] KIT | American Bioproducts Co. | 1992-10-26 | Traditional | PDF ↗ |
| K921344 | THROMBO-CALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 | Traditional | PDF ↗ |
| K914949 | COAGULATION ARPR,CAT.NO.5185 | Helena Laboratories | 1992-03-04 | Traditional | PDF ↗ |
| K911777 | ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED | Helena Laboratories | 1991-08-22 | Traditional | PDF ↗ |
| K905673 | AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 | Helena Laboratories | 1991-02-11 | Traditional | PDF ↗ |
| K902362 | COAGULATION CONTROL, LEVEL II | Sigma Chemical Co. | 1990-07-26 | Traditional | PDF ↗ |
| K902361 | COAGULATION CONTROL, LEVEL I | Sigma Chemical Co. | 1990-07-26 | Traditional | PDF ↗ |
| K902363 | COAGULATION CONTROL, LEVEL III | Sigma Chemical Co. | 1990-07-26 | Traditional | PDF ↗ |
| K902210 | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA | Ortho Diagnostic Systems, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K900019 | ROCKET REFERENCE PLASMA, CAT NO. 5188 | Helena Laboratories | 1990-01-25 | Traditional | PDF ↗ |
| K884901 | DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO | Baxter Healthcare Corp | 1989-02-02 | Traditional | PDF ↗ |
| K884854 | COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) | Precision Biologicals, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | International Technidyne Corp. | 1988-08-30 | Traditional | PDF ↗ |
| K882480 | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II | International Technidyne Corp. | 1988-08-30 | Traditional | PDF ↗ |
| K881348 | VERIFY(R) REFERENCE PLASMA | Organon Teknika Corp. | 1988-05-02 | Traditional | PDF ↗ |
| K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER | Hemotec, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K840288 | DIACELIN | Diatech, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K834086 | CONTACT-K APTT REAGENT | Pacific Hemostasis | 1984-02-03 | Traditional | PDF ↗ |
| K771346 | CI-TROL COAGULATION CONTROLS II & III | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-22 | Traditional | PDF ↗ |
Product code GGN · Class II · Hematology. Data: openFDA.