PARAMAX ALANINE AMINOTRANSFERASE REAGENT— 510(k) K901105

Name: FDA 510(k) clearance K901105
Creator: U.S. Food and Drug Administration
Published: 1990-03-23

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K901105 for PARAMAX ALANINE AMINOTRANSFERASE REAGENT, Substantially Equivalent on 1990-03-23. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CKA
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1990-03-08
Decision date: 1990-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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