Panels › Hematology › Product code GGW · Class 2
Test, Time, Partial Thromboplastin
Regulation 864.7925
1510(k)s in 12 months (32 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GGW
| Company | 510(k)s | Recalls |
|---|---|---|
| American Bioproducts Co. | 4 | 0 |
| Bio/Data Corp. | 3 | 0 |
| Helena Laboratories | 3 | 0 |
| American Dade | 2 | 0 |
| R2 Diagnostics, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Abbott Laboratories | 1 | 0 |
| Aniara Diagnostica, LLC | 1 | 0 |
| Axis-Shield Doc AS | 1 | 0 |
| Biosearch Medical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2026 | K260551 | HemosIL Factor V Leiden (APC Resistance V) Instrumentation Laboratory (IL) Co. | GGW |
| Dec 30, 2010 | K090105 | LUPOTEK KCT R2 Diagnostics, Inc. | GGW |
| May 8, 2009 | 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 | GGW |
| May 10, 2006 | K060284 | CRYOCHECK CLOT APCR Precision Biologic, Inc., CA | GGW |
| Dec 22, 2004 | K042762 | PEFAKIT APC-R FACTOR V LEIDEN Pentapharm , Ltd. | GGW |
| Feb 4, 2004 | K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE R2 Diagnostics, Inc. | GGW |
| Dec 21, 1999 | K992456 | GRADILEIDEN V TEST Gradipore , Ltd., AU | GGW |
| Jan 13, 1999 | K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 Precision Biologicals, Inc., CA | GGW |
| Dec 23, 1996 | K963111 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S Chromogenix AB | GGW |
| Aug 7, 1995 | K945940 | COATEST(R) APC(TM) RESISTANCE Axis-Shield Doc AS | GGW |
| Mar 21, 1995 | K941210 | PTT-LT TEST KIT American Bioproducts Co. | GGW |
| Aug 9, 1993 | K924370 | STACLOT(R) PNP TEST KIT American Bioproducts Co. | GGW |
| Jun 9, 1992 | K921684 | PTT-LA TEST KIT American Bioproducts Co. | GGW |
| Jan 23, 1992 | K915463 | ACTIVATED PARTIAL THROMBOPLASTIN TIME Sigma Diagnostics, Inc. | GGW |
| Aug 14, 1990 | K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT Biosearch Medical Products, Inc. | GGW |
| Nov 20, 1987 | K873382 | PLATELET EXTRACT REAGENT Bio/Data Corp. | GGW |
| Oct 17, 1986 | K863594 | ACTIN FSL ACTIVATED PTT REAGENT American Dade | GGW |
| Jun 23, 1986 | K861190 | PTT AUTOMATE TEST KIT American Bioproducts Co. | GGW |
| Oct 10, 1985 | K853897 | CITREX H Bio/Data Corp. | GGW |
| Aug 12, 1985 | K852195 | CEPHALINEX ACTIVATED PTT REAGENT Bio/Data Corp. | GGW |
| May 29, 1985 | K851126 | ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC E.I. Dupont DE Nemours & Co., Inc. | GGW |
| Apr 30, 1984 | K841522 | CALCIUM CHLORIDE Diatech, Inc. | GGW |
| Apr 5, 1983 | K830320 | ACTIVAT-PARTIAL THROMBO-PLASTIN Helena Laboratories | GGW |
| Oct 8, 1982 | K822782 | ACUSCREEN Ortho Diagnostic Systems, Inc. | GGW |
| Jul 16, 1981 | K811589 | ACTIN FS ACTIVATED PTT REAGENT American Dade | GGW |
| Nov 12, 1980 | K802232 | AB-TROL COAGULATION CONTROL Helena Laboratories | GGW |
| Sep 9, 1980 | K801932 | HEP-TROL Helena Laboratories | GGW |
| Jul 28, 1980 | K801460 | PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT Pacific Hemostasis | GGW |
| Jul 21, 1980 | K800925 | VERIFY S PROD. #34141 General Diagnostics | GGW |
| Jul 14, 1980 | K800787 | ANTIBODY TO VARICELLA-ZOSTER VIRUS Electro-Nucleonics Laboratories, Inc. | GGW |
| Jun 4, 1980 | K800725 | A-GENT QUANTICHROM THROMBIGEN I Abbott Laboratories | GGW |
| Nov 5, 1979 | K792048 | LANCER COAGENT APTT KIT Sherwood Medical Co. | GGW |
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