SIGMA SUDAN BLACK REAGENT 380-1
FDA 510(k) clearance K843684 · decided 1984-10-31
Clearance details
- K-number
- K843684
- Device name
- SIGMA SUDAN BLACK REAGENT 380-1
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-18
- Decision date
- 1984-10-31
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- HZZ
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| AMIDO BLACK 10B STAIN (K792552) | Electrophoresis Corp. of America | 1979-12-18 |
Recalls involving this device
No recalls on record reference this clearance.