Test, Leukocyte Alkaline Phosphatase
The Test, Leukocyte Alkaline Phosphatase (product code GHD) is a hematology staining reagent system used to cytochemically assess alkaline phosphatase activity in neutrophils, which assists in differentiating chronic myelogenous leukemia from other myeloproliferative disorders. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.7660 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GHD
- Device Class
- FDA class 1
- Regulation Number
- 864.7660
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904022 | NITRO BLUE TETRAZOLIUM REDUCTION | Dec 18, 1990 | Substantially Equivalent | Sigma Chemical Co. |
| K903995 | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | Dec 13, 1990 | Substantially Equivalent | Sigma Chemical Co. |
| K896092 | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | Nov 09, 1989 | Substantially Equivalent | Sigma Chemical Co. |
| K811189 | CHEMSTRIP L | Jul 27, 1981 | Substantially Equivalent | Biodynamics Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.