ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14— 510(k) K912809

Name: FDA 510(k) clearance K912809
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K912809 for ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14, Substantially Equivalent on 1991-08-12. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1991-06-25
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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