GGW — Test, Time, Partial Thromboplastin Class II
FDA Device Classification
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 |
|---|
| 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 |
| K851126 | e.i. dupont de nemours and co | ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC | May 29, 1985 |