FAST'N'FLAMMATORY KIT
FDA 510(k) clearance K931241 · decided 1994-02-03
Clearance details
- K-number
- K931241
- Device name
- FAST'N'FLAMMATORY KIT
- Applicant
- Techlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-11
- Decision date
- 1994-02-03
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- GIA
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Blacksburg, VA, 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 |
|---|---|---|
| SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR (K844402) | Sigma Chemical Co. | 1985-01-04 |
| HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011) | Sigma Chemical Co. | 1981-05-15 |
Recalls involving this device
No recalls on record reference this clearance.