Product code GGW
- Device name
- Test, Time, 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 |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | 2026-03-20 |
| K090105 | LUPOTEK KCT | R2 Diagnostics, Inc. | 2010-12-30 |
| K083729 | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN | Aniara Diagnostica, LLC | 2009-05-08 |
| K060284 | CRYOCHECK CLOT APCR | Precision Biologic, Inc. | 2006-05-10 |
| K042762 | PEFAKIT APC-R FACTOR V LEIDEN | Pentapharm , Ltd. | 2004-12-22 |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | R2 Diagnostics, Inc. | 2004-02-04 |
| K992456 | GRADILEIDEN V TEST | Gradipore , Ltd. | 1999-12-21 |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | Precision Biologicals, Inc. | 1999-01-13 |
| K963111 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S | Chromogenix AB | 1996-12-23 |
| K945940 | COATEST(R) APC(TM) RESISTANCE | Axis-Shield Doc AS | 1995-08-07 |
| K941210 | PTT-LT TEST KIT | American Bioproducts Co. | 1995-03-21 |
| K924370 | STACLOT(R) PNP TEST KIT | American Bioproducts Co. | 1993-08-09 |
| K921684 | PTT-LA TEST KIT | American Bioproducts Co. | 1992-06-09 |
| K915463 | ACTIVATED PARTIAL THROMBOPLASTIN TIME | Sigma Diagnostics, Inc. | 1992-01-23 |
| K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | Biosearch Medical Products, Inc. | 1990-08-14 |
| K873382 | PLATELET EXTRACT REAGENT | Bio/Data Corp. | 1987-11-20 |
| K863594 | ACTIN FSL ACTIVATED PTT REAGENT | American Dade | 1986-10-17 |
| K861190 | PTT AUTOMATE TEST KIT | American Bioproducts Co. | 1986-06-23 |
| K853897 | CITREX H | Bio/Data Corp. | 1985-10-10 |
| K852195 | CEPHALINEX ACTIVATED PTT REAGENT | Bio/Data Corp. | 1985-08-12 |
| K851126 | ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC | E.I. Dupont DE Nemours & Co., Inc. | 1985-05-29 |
| K841522 | CALCIUM CHLORIDE | Diatech, Inc. | 1984-04-30 |
| K830320 | ACTIVAT-PARTIAL THROMBO-PLASTIN | Helena Laboratories | 1983-04-05 |
| K822782 | ACUSCREEN | Ortho Diagnostic Systems, Inc. | 1982-10-08 |
| K811589 | ACTIN FS ACTIVATED PTT REAGENT | American Dade | 1981-07-16 |
| K802232 | AB-TROL COAGULATION CONTROL | Helena Laboratories | 1980-11-12 |
| K801932 | HEP-TROL | Helena Laboratories | 1980-09-09 |
| K801460 | PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT | Pacific Hemostasis | 1980-07-28 |
| K800925 | VERIFY S PROD. #34141 | General Diagnostics | 1980-07-21 |
| K800787 | ANTIBODY TO VARICELLA-ZOSTER VIRUS | Electro-Nucleonics Laboratories, Inc. | 1980-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842768019555 | Dade Actin FSL Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640242 | Dade Actin FSL Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640327 | Dade Actin FS Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640341 | Dade Actin FS Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640358 | Dade Actin FSL Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019562 | Dade Actin FS Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639758 | Factor V Leiden | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 03607450012620 | PTT-LA | DIAGNOSTICA STAGO | 2021-03-23 |
| 13607450012627 | PTT-LA | DIAGNOSTICA STAGO | 2021-03-23 |
| 07640175460013 | Pefakit | Pentapharm AG | 2017-01-25 |
| 10859394006016 | Phospholin ES w/ Calcium Chloride | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006238 | Phospholin ES w/Calcium | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006146 | LupoTek KCT | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00842768003882 | Dade® Actin® FSL Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768003875 | Dade® Actin® FSL Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768003868 | Dade® Actin® FS Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768003844 | Dade® Actin® FS Activated PTT Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768033520 | Factor V Leiden | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 08426950088912 | Coatest APCR Control Plasma Level 1 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950088929 | Coatest APCR Control Plasma Level 2 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950087656 | HemosIL Factor V Reagent Plasma (for APC R V) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950062424 | HemosIL Factor V Leiden (APC Resistance V) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950060147 | Coatest APC Resistance | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950060017 | Coatest APC Resistance V | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950076100 | Coatest APC Resistance V-S | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 03607450005974 | STA® - C.K. Prest® 5 | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450005957 | STA® - PTT A 5 | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450005995 | PTT-LA | DIAGNOSTICA STAGO | 2016-09-15 |
| M52551870 | AB-TROL 2 Coagulation Control | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 03663537017964 | HEMOCLOT Quanti. V-L | HYPHEN BIOMED | 2016-08-25 |