ICL — Carbol Fuchsin Class I
FDA product code ICL covers "Carbol Fuchsin", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ICL
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K890148 | alpha-tec systems | ATS TB RAPID STAIN SET PRODUCT #034-45 | January 24, 1989 |
| K842933 | e k ind | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | September 11, 1984 |
| K792483 | laboratory products | STAINS, COUNTERSTAINS & GEN. PURPOSE | December 18, 1979 |
| K771390 | harleco | HISTOCHEMICAL AFB DEMONSTRATION | August 22, 1977 |