# K991762: Alkaline Phophatase (Alp), Product No's 118-01, 118-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: Sep 2, 1999 after 101 days
- Product code: CJE (Nitrophenylphosphate, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This Alkaline Phosphatase procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of Alkaline Phosphatase in serum. Measurments of Alkaline Phosphatase or its isoenzymes are use in the diagnostics and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K991762
Methodology: https://510kreport.com/methodology