ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38— 510(k) K913921

Name: FDA 510(k) clearance K913921
Creator: U.S. Food and Drug Administration
Published: 1991-11-22

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913921 for ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38, Substantially Equivalent on 1991-11-22. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1991-09-03
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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