RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT— 510(k) K934013

Name: FDA 510(k) clearance K934013
Creator: U.S. Food and Drug Administration
Published: 1994-04-26

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K934013 for RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT, Substantially Equivalent on 1994-04-26. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1993-08-18
Decision date: 1994-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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