Product code GFO
- Device name
- Activated Partial Thromboplastin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7925
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026-01-09 |
| K193556 | Cryocheck Hex LA | Precision Biologic | 2020-10-23 |
| K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016-03-16 |
| K053111 | STA-CEPHASCREEN KIT | Diagnostica Stago, Inc. | 2006-05-04 |
| K060688 | HEMOSIL SYNTHASIL | Instrumentation Laboratory CO | 2006-04-13 |
| K050221 | HEMOSIL SILICA CLOTTING TIME | Instrumentation Laboratory CO | 2005-03-30 |
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Vital Scientific N.V. | 2002-11-01 |
| K014028 | CARESIDE APTT | Careside Hemotology, Inc. | 2002-02-08 |
| K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE | Itc, Inc. | 2002-01-24 |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | Sigma Diagnostics, Inc. | 1999-12-06 |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | Sigma Diagnostics, Inc. | 1999-12-06 |
| K972831 | HEMOCHRON CITRATE APTT | International Technidyne Corp. | 1997-11-20 |
| K973306 | IL TEST APTT-SP | Instrumentation Laboratory CO | 1997-11-04 |
| K961892 | SPECKTIN-LA TEST SET | Analytical Control Systems, Inc. | 1997-03-07 |
| K955638 | SYNTHAFAX APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1996-04-23 |
| K955450 | PATHROMTIN SL | Behring Diagnostics, Inc. | 1996-04-19 |
| K953981 | SYNTHASIL APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1995-11-30 |
| K935169 | APTT-ES | Helena Laboratories | 1994-12-02 |
| K934351 | APTT-ES REAGENT | Medical Diagnostic Technologies, Inc. | 1993-12-06 |
| K932011 | PATHROMTIN | Behring Diagnostics, Inc. | 1993-10-25 |
| K926012 | ACS APCT REAGENT, MODIFIED | Analytical Control Systems, Inc. | 1993-04-27 |
| K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT | International Technidyne Corp. | 1993-01-27 |
| K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT | International Technidyne Corp. | 1993-01-14 |
| K923731 | STACLOT LA TEST KIT | American Bioproducts Co. | 1992-12-23 |
| K921396 | PLATELIN L | Organon Teknika Corp. | 1992-10-19 |
| K921223 | ACS FREEZE-DRIED APTT REAGENT | Analytical Control Systems, Inc. | 1992-08-18 |
| K921118 | ACS APCT REAGENT | Analytical Control Systems, Inc. | 1992-07-28 |
| K915418 | ELLAGIC ACID APTT REAGENT | Helena Laboratories | 1992-02-14 |
| K915344 | HEMOCHRON ONESTEP APTT TEST | International Technidyne Corp. | 1992-02-11 |
| K911994 | HEMOCHRON(R) APTT, MODIFICATION | International Technidyne Corp. | 1991-07-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842768019074 | Pathromtin SL | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019579 | Dade Actin Activated Cephaloplastin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640310 | Dade Actin Activated Cephaloplastin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640334 | Dade Actin Activated Cephaloplastin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640709 | Pathromtin SL | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640716 | Pathromtin SL | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00850053916199 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 00843876000596 | CRYOcheck Hex LA | Precision Biologic Inc | 2023-05-02 |
| 00843876000527 | CRYOcheck Hex LA | Precision Biologic Inc | 2020-11-05 |
| 00843876000510 | CRYOcheck Hex LA | Precision Biologic Inc | 2020-11-05 |
| 00817869020014 | Slide Platelet Aggregation Test Reagent | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 08426950087632 | HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950087649 | HemosIL SynthAFax | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950433491 | HemosIL Silica Clotting Time | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950023487 | HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950078920 | HemosIL SynthASil | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950078937 | HemosIL APTT-SP | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950915676 | GEM TEST APTT CITRATE | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 00627944000103 | QuikCoag Calcium Choride 0.02M | Biomedica Diagnostics Inc | 2016-09-22 |
| 00627944000097 | QuikCoag Calcium Chloride 0.02M | Biomedica Diagnostics Inc | 2016-09-22 |
| 10711234103029 | Hemochron Whole Blood Microcoagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 13607450003083 | STA® - Cephascreen® 4 | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450003106 | STA® - Cephascreen® 10 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006001 | Staclot® LA | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450005943 | Staclot® LA 20 | DIAGNOSTICA STAGO | 2016-09-15 |
| 15391521420333 | TriniCLOT™ Automated aPTT 6 mL | TCOAG IRELAND LIMITED | 2016-09-12 |
| M52553890 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553880 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553870 | APTT-SA (Soluble Activator) Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553860 | 0.25 M Calcium Chloride | HELENA LABORATORIES CORPORATION | 2016-09-07 |