GGW · Test, Time, Partial Thromboplastin
Hematology · 21 CFR 864.7925 · Class 2
Overview
| Product Code | GGW |
|---|---|
| Device Name | Test, Time, Partial Thromboplastin |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | Mar 20, 2026 | SESE |
| K090105 | LUPOTEK KCT | R2 Diagnostics, Inc. | Dec 30, 2010 | SESE |
| 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 | May 8, 2009 | SESE |
| K060284 | CRYOCHECK CLOT APCR | Precision Biologic, Inc. | May 10, 2006 | SESE |
| K042762 | PEFAKIT APC-R FACTOR V LEIDEN | Pentapharm , Ltd. | Dec 22, 2004 | SESE |
| K033471 | PHOSPHOLIN ES AND CALCIUM CHLORIDE | R2 Diagnostics, Inc. | Feb 4, 2004 | SESE |
| K992456 | GRADILEIDEN V TEST | Gradipore , Ltd. | Dec 21, 1999 | SESE |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | Precision Biologicals, Inc. | Jan 13, 1999 | SESE |
| K963111 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S | Chromogenix AB | Dec 23, 1996 | SESE |
| K945940 | COATEST(R) APC(TM) RESISTANCE | Axis-Shield Doc AS | Aug 7, 1995 | SESE |
| K941210 | PTT-LT TEST KIT | American Bioproducts Co. | Mar 21, 1995 | SESK |
| K924370 | STACLOT(R) PNP TEST KIT | American Bioproducts Co. | Aug 9, 1993 | SESE |
| K921684 | PTT-LA TEST KIT | American Bioproducts Co. | Jun 9, 1992 | SESE |
| K915463 | ACTIVATED PARTIAL THROMBOPLASTIN TIME | Sigma Diagnostics, Inc. | Jan 23, 1992 | SESE |
| K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | Biosearch Medical Products, Inc. | Aug 14, 1990 | SESE |
| K873382 | PLATELET EXTRACT REAGENT | Bio/Data Corp. | Nov 20, 1987 | SESE |
| K863594 | ACTIN FSL ACTIVATED PTT REAGENT | American Dade | Oct 17, 1986 | SESE |
| K861190 | PTT AUTOMATE TEST KIT | American Bioproducts Co. | Jun 23, 1986 | SESE |
| K853897 | CITREX H | Bio/Data Corp. | Oct 10, 1985 | SESE |
| K852195 | CEPHALINEX ACTIVATED PTT REAGENT | Bio/Data Corp. | Aug 12, 1985 | SESE |
Top Applicants
- American Bioproducts Co. — 4 clearances
- Bio/Data Corp. — 3 clearances
- Helena Laboratories — 3 clearances
- American Dade — 2 clearances
- R2 Diagnostics, Inc. — 2 clearances
