SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
FDA 510(k) clearance K844402 · decided 1985-01-04
Clearance details
- K-number
- K844402
- Device name
- SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-01-04
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- GIA
- Device class
- 1
- Regulation number
- 864.7675
- 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 |
|---|---|---|
| FAST'N'FLAMMATORY KIT (K931241) | Techlab, Inc. | 1994-02-03 |
| HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011) | Sigma Chemical Co. | 1981-05-15 |
Recalls involving this device
No recalls on record reference this clearance.