OPUS D-DIMER
FDA 510(k) clearance K972316 · decided 1997-09-09
Clearance details
- K-number
- K972316
- Device name
- OPUS D-DIMER
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-20
- Decision date
- 1997-09-09
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GHH
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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 |
| PATHFAST D-DIMER (K072288) | Mitsubishi Kagaku Iatron | 2009-05-06 |
| OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL (K070453) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-11 |
| 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 |
| AGEN DIMERTEST GOLD EIA (K945642) | Agen Biomedical , Ltd. | 1995-10-25 |
| FDP - SLIDEX DIRECT (K921989) | Biomerieux Vitek, Inc. | 1993-11-03 |
| MINUTEX D-DIMER LATEX TEST (K920668) | Biopool AB | 1992-10-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |