# K963383: Hichem Alp/Amp Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hichem Diagnostics
- Decided: Sep 23, 1996 after 27 days
- Product code: CKF (Phenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BMD Alkaline Phosphatase/AMP Reagent: named in the summary without a submission number
- (no number) MAS ALP Reagent: named in the summary without a submission number

## Indications for use
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.

Source page: https://510kreport.com/device/K963383
Methodology: https://510kreport.com/methodology