TRIAGE D-DIMER TEST, MODEL 98100
FDA 510(k) clearance K042890 · decided 2004-11-29
Clearance details
- K-number
- K042890
- Device name
- TRIAGE D-DIMER TEST, MODEL 98100
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2004-10-19
- Decision date
- 2004-11-29
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GHH
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- 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 |
| 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 |
| 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 |
| MINUTEX D-DIMER LATEX TEST (K920668) | Biopool AB | 1992-10-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluore recall (Z-1727-2014) | Alere San Diego, Inc. | 2014-06-06 |
| Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspec recall (Z-1932-2012) | Alere San Diego, Inc. | 2012-07-06 |