ICL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Carbol Fuchsin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ATS TB RAPID STAIN SET PRODUCT #034-45 (K890148) | Alpha-Tec Systems, Inc. | 1989-01-24 |
| CARBOL-FUCHSIN, ZIEHL-NEEDSEN (K842933) | E K Ind., Inc. | 1984-09-11 |
| STAINS, COUNTERSTAINS & GEN. PURPOSE (K792483) | Laboratory Products, Inc. | 1979-12-18 |
| HISTOCHEMICAL AFB DEMONSTRATION (K771390) | Harleco | 1977-08-22 |
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Every clearance here is in the API, with alerts when new ones post.