DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
FDA 510(k) clearance K872360 · decided 1987-07-06
Clearance details
- K-number
- K872360
- Device name
- DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1987-06-18
- Decision date
- 1987-07-06
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- GHH
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E recall (Z-1040-05) | Dade Behring , Inc. | 2005-07-22 |