MDA D-DIMER
FDA 510(k) clearance K974776 · decided 1998-04-16
Clearance details
- K-number
- K974776
- Device name
- MDA D-DIMER
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-22
- Decision date
- 1998-04-16
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- DAP
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Durham, NC, 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 |
|---|---|---|
| HemosIL D-Dimer HS 500 (K172903) | Instrumentation Laboratory CO | 2017-11-22 |
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| HemosIL D-Dimer HS (K160885) | Instrumentation Laboratory CO | 2016-10-27 |
| HemosIL D-Dimer HS (K151534) | Instrumentation Laboratory CO | 2015-07-06 |
| STA LIATEST D-DI (K141144) | Diagnostica Stago | 2014-09-03 |
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |
| STRATUS CS ACUTE CARE D-DIMER (K110303) | Siemens Healthcare Diagnostics | 2011-05-16 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
| HEMOSIL D-DIMER HS 500, CONTROLS (K090264) | Instrumentation Laboratory CO | 2010-02-05 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K091916) | Siemens Healthcare Diagnostics | 2009-10-29 |
| INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732) | Siemens Healthcare Diagnostics | 2008-10-24 |
| HEMOSIL D-DIMER (K073042) | Instrumentation Laboratory | 2008-07-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001) | Organon Teknika Corp. | 1990-03-21 |
| HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001) | Organon Teknika Corp. | 1990-03-21 |
| 9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001) | Organon Teknika Corp. | 1990-03-21 |
| AUTOBAC MIC TEST SYSTEM (N50524/S033) | Organon Teknika Corp. | 1990-01-22 |
| AUTOBAC MIC TEST SYSTEM (N50524/S035) | Organon Teknika Corp. | 1989-12-07 |
| AUTOBAC MIC TEST SYSTEM (N50524/S032) | Organon Teknika Corp. | 1989-06-13 |
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018) | Organon Teknika Corp. | 1989-02-06 |
| AUTOBAC MIC TEST SYSTEM (N50524/S031) | Organon Teknika Corp. | 1988-12-28 |