Panels › Hematology › Product code GFO · Class 2
Activated Partial Thromboplastin
Regulation 864.7925
1510(k)s in 12 months (52 all time)
2recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in GFO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K253957 | HemosIL Silica Clotting Time Instrumentation Laboratory (IL) Co. | GFO |
| Oct 23, 2020 | K193556 | Cryocheck Hex LA Precision Biologic, CA | GFO |
| Mar 16, 2016 | K160445 | HemosIL Silica Clotting Time Instrumentation Laboratory CO | GFO |
| May 4, 2006 | K053111 | STA-CEPHASCREEN KIT Diagnostica Stago, Inc. | GFO |
| Apr 13, 2006 | K060688 | HEMOSIL SYNTHASIL Instrumentation Laboratory CO | GFO |
| Mar 30, 2005 | K050221 | HEMOSIL SILICA CLOTTING TIME Instrumentation Laboratory CO | GFO |
| Nov 1, 2002 | K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT Vital Scientific N.V. | GFO |
| Feb 8, 2002 | K014028 | CARESIDE APTT Careside Hemotology, Inc. | GFO |
| Jan 24, 2002 | K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE Itc, Inc. | GFO |
| Dec 6, 1999 | K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 Sigma Diagnostics, Inc. | GFO |
| Dec 6, 1999 | K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 Sigma Diagnostics, Inc. | GFO |
| Nov 20, 1997 | K972831 | HEMOCHRON CITRATE APTT International Technidyne Corp. | GFO |
| Nov 4, 1997 | K973306 | IL TEST APTT-SP Instrumentation Laboratory CO | GFO |
| Mar 7, 1997 | K961892 | SPECKTIN-LA TEST SET Analytical Control Systems, Inc. | GFO |
| Apr 23, 1996 | K955638 | SYNTHAFAX APTT REAGENT Ortho Diagnostic Systems, Inc. | GFO |
| Apr 19, 1996 | K955450 | PATHROMTIN SL Behring Diagnostics, Inc. | GFO |
| Nov 30, 1995 | K953981 | SYNTHASIL APTT REAGENT Ortho Diagnostic Systems, Inc. | GFO |
| Dec 2, 1994 | K935169 | APTT-ES Helena Laboratories | GFO |
| Dec 6, 1993 | K934351 | APTT-ES REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Oct 25, 1993 | K932011 | PATHROMTIN Behring Diagnostics, Inc. | GFO |
| Apr 27, 1993 | K926012 | ACS APCT REAGENT, MODIFIED Analytical Control Systems, Inc. | GFO |
| Jan 27, 1993 | K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT International Technidyne Corp. | GFO |
| Jan 14, 1993 | K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT International Technidyne Corp. | GFO |
| Dec 23, 1992 | K923731 | STACLOT LA TEST KIT American Bioproducts Co. | GFO |
| Oct 19, 1992 | K921396 | PLATELIN L Organon Teknika Corp. | GFO |
| Aug 18, 1992 | K921223 | ACS FREEZE-DRIED APTT REAGENT Analytical Control Systems, Inc. | GFO |
| Jul 28, 1992 | K921118 | ACS APCT REAGENT Analytical Control Systems, Inc. | GFO |
| Feb 14, 1992 | K915418 | ELLAGIC ACID APTT REAGENT Helena Laboratories | GFO |
| Feb 11, 1992 | K915344 | HEMOCHRON ONESTEP APTT TEST International Technidyne Corp. | GFO |
| Jul 17, 1991 | K911994 | HEMOCHRON(R) APTT, MODIFICATION International Technidyne Corp. | GFO |
| Jan 25, 1991 | K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM Medical Innovations Corp. | GFO |
| Jan 14, 1991 | K905301 | THE THERATEST ACA TEST Theratest Laboratories, Inc. | GFO |
| Nov 8, 1990 | K904341 | APTT REAGENT Sigma Chemical Co. | GFO |
| Aug 6, 1990 | K902556 | ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Analytical Control Systems, Inc. | GFO |
| Jan 25, 1990 | K900049 | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Dec 1, 1989 | K896545 | ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) Sigma Chemical Co. | GFO |
| Oct 6, 1989 | K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Jun 22, 1989 | K892209 | APTT BY HEMOCHRON(R) Intensive Technology, Inc. | GFO |
| May 22, 1989 | K891015 | COAG-1 APTT TEST CARD Cardiovascular Diagnostic Services | GFO |
| Apr 21, 1989 | K891337 | THROMBOSCREEN APTT REAGENT Pacific Hemostasis | GFO |
| Apr 21, 1989 | K890859 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME Elite Diagnostic , Ltd. | GFO |
| Mar 15, 1989 | K890619 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT Elite Diagnostic , Ltd. | GFO |
| Feb 24, 1989 | K890052 | BIOTRACK APTT REAGENT CARTRIDGE Biotrack, Inc. | GFO |
| Jan 30, 1989 | K884856 | APTT REAGENT Precision Biologicals, Inc., CA | GFO |
| Jan 27, 1989 | K884702 | EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 Em Diagnostic Systems, Inc. | GFO |
| Dec 28, 1988 | K884485 | KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT King Diagnostics, Inc. | GFO |
| Aug 25, 1988 | K882325 | UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Sclavo, Inc. | GFO |
| Mar 23, 1988 | K881068 | CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Creative Laboratory Products, Inc. | GFO |
| Apr 26, 1982 | K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM Hyland Therapeutic Div., Travenol Laboratories | GFO |
| Aug 10, 1978 | K781104 | PLASMA COAGULATION CONT., ABNORMAL Ortho Diagnostics, Inc. | GFO |
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