SIMPLIFY D-DIMER, MODEL DCGK1
FDA 510(k) clearance K993276 · decided 1999-12-14
Clearance details
- K-number
- K993276
- Device name
- SIMPLIFY D-DIMER, MODEL DCGK1
- Applicant
- Agen Biomedical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-30
- Decision date
- 1999-12-14
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GHH
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Brisbane, Queensland, AU
- Third-party review
- No
- Expedited review
- No
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| OPUS D-DIMER (K972316) | Behring Diagnostics, Inc. | 1997-09-09 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in hu recall (Z-0594-2007) | Inverness Medical Professional Diagnostics | 2007-03-13 |