GGW — Test, Time, Partial Thromboplastin Class II
FDA product code GGW covers "Test, Time, Partial Thromboplastin", a Class II medical device regulated under 21 CFR 864.7925. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGW
- Device Class
- Class II
- Regulation Number
- 864.7925
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260551 | instrumentation laboratory (il) | HemosIL Factor V Leiden (APC Resistance V) | March 20, 2026 |
| K090105 | r2 diagnostics | LUPOTEK KCT | December 30, 2010 |
| K083729 | aniara diagnostica | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHE | May 8, 2009 |
| K060284 | precision biologic | CRYOCHECK CLOT APCR | May 10, 2006 |
| K042762 | pentapharm | PEFAKIT APC-R FACTOR V LEIDEN | December 22, 2004 |
| K033471 | r2 diagnostics | PHOSPHOLIN ES AND CALCIUM CHLORIDE | February 4, 2004 |
| K992456 | gradipore | GRADILEIDEN V TEST | December 21, 1999 |
| K982062 | precision biologicals | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | January 13, 1999 |
| K963111 | chromogenix | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S | December 23, 1996 |
| K945940 | axis-shield doc | COATEST(R) APC(TM) RESISTANCE | August 7, 1995 |
| K941210 | american bioproducts | PTT-LT TEST KIT | March 21, 1995 |
| K924370 | american bioproducts | STACLOT(R) PNP TEST KIT | August 9, 1993 |
| K921684 | american bioproducts | PTT-LA TEST KIT | June 9, 1992 |
| K915463 | sigma diagnostics | ACTIVATED PARTIAL THROMBOPLASTIN TIME | January 23, 1992 |
| K902236 | biosearch medical products | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | August 14, 1990 |
| K873382 | bio/data | PLATELET EXTRACT REAGENT | November 20, 1987 |
| K863594 | american dade | ACTIN FSL ACTIVATED PTT REAGENT | October 17, 1986 |
| K861190 | american bioproducts | PTT AUTOMATE TEST KIT | June 23, 1986 |
| K853897 | bio/data | CITREX H | October 10, 1985 |
| K852195 | bio/data | CEPHALINEX ACTIVATED PTT REAGENT | August 12, 1985 |