KINETIC ALKALINE PHOSPHATASE REAGENT KIT— 510(k) K861638

Name: FDA 510(k) clearance K861638
Creator: U.S. Food and Drug Administration
Published: 1986-05-29

Substantially Equivalent

Bio-Analytics Laboratories, Inc.

FDA 510(k) clearance K861638 for KINETIC ALKALINE PHOSPHATASE REAGENT KIT, Substantially Equivalent on 1986-05-29. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Analytics Laboratories, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1986-04-30
Decision date: 1986-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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