ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651— 510(k) K884549

Name: FDA 510(k) clearance K884549
Creator: U.S. Food and Drug Administration
Published: 1988-11-10

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K884549 for ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651, Substantially Equivalent on 1988-11-10. 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: 1988-10-31
Decision date: 1988-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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