ENZYMATIC ALPHA-AMYLASE REAGENT KIT— 510(k) K850639

Name: FDA 510(k) clearance K850639
Creator: U.S. Food and Drug Administration
Published: 1985-03-05

Substantially Equivalent

Bio-Analytics Laboratories, Inc.

FDA 510(k) clearance K850639 for ENZYMATIC ALPHA-AMYLASE REAGENT KIT, Substantially Equivalent on 1985-03-05. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Analytics Laboratories, Inc.
Product code: Code CIW
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1985-02-19
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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