GHD — Test, Leukocyte Alkaline Phosphatase Class I
FDA product code GHD covers "Test, Leukocyte Alkaline Phosphatase", a Class I medical device regulated under 21 CFR 864.7660. 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
- GHD
- Device Class
- Class I
- Regulation Number
- 864.7660
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K904022 | sigma chemical | NITRO BLUE TETRAZOLIUM REDUCTION | December 18, 1990 |
| K903995 | sigma chemical | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | December 13, 1990 |
| K896092 | sigma chemical | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | November 9, 1989 |
| K811189 | biodynamics | CHEMSTRIP L | July 27, 1981 |