ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02— 510(k) K991762

Name: FDA 510(k) clearance K991762
Creator: U.S. Food and Drug Administration
Published: 1999-09-02

Substantially Equivalent

A.P. Total Care, Inc.

FDA 510(k) clearance K991762 for ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02, Substantially Equivalent on 1999-09-02. Applicant: A.P. Total Care, Inc.. Device class: 2.

Clearance details

Applicant: A.P. Total Care, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1999-05-24
Decision date: 1999-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, CT, US

Download summary PDF View on FDA.gov ↗

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