GIA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Leukocyte Peroxidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FAST'N'FLAMMATORY KIT (K931241) | Techlab, Inc. | 1994-02-03 |
| SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR (K844402) | Sigma Chemical Co. | 1985-01-04 |
| HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011) | Sigma Chemical Co. | 1981-05-15 |
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Every clearance here is in the API, with alerts when new ones post.