MINUTEX D-DIMER LATEX TEST
FDA 510(k) clearance K920668 · decided 1992-10-16
Clearance details
- K-number
- K920668
- Device name
- MINUTEX D-DIMER LATEX TEST
- Applicant
- Biopool AB
- Decision
- Substantially Equivalent
- Date received
- 1992-02-13
- Decision date
- 1992-10-16
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- GHH
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ontario, L7l 6b8, CA
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (K112120) | Diazyme Laboratories | 2013-01-24 |
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| TINA-QUANT D-DIMER TEST SYSTEM (K062203) | Roche Diagnostics Corp. | 2007-03-14 |
| TRIAGE D-DIMER TEST, MODEL 98100 (K042890) | Biosite Incorporated | 2004-11-29 |
| MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (K030740) | Roche Diagnostics Corp. | 2003-04-01 |
| MDA D-DIMER (K021877) | bioMerieux, Inc. | 2002-08-07 |
| TINA-QUANT D-DIMER TEST SYSTEM (K011143) | Roche Diagnostics Corp. | 2001-05-29 |
| SIMPLIFY D-DIMER, MODEL DCGK1 (K993276) | Agen Biomedical , Ltd. | 1999-12-14 |
| OPUS D-DIMER (K972316) | Behring Diagnostics, Inc. | 1997-09-09 |
| AGEN DIMERTEST GOLD EIA (K945642) | Agen Biomedical , Ltd. | 1995-10-25 |
| FDP - SLIDEX DIRECT (K921989) | Biomerieux Vitek, Inc. | 1993-11-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, recall (Z-0030-2012) | Tcoag Us, Incorporated | 2011-10-07 |