BICARBONATE TEST ITEM NUMBER: SR1006— 510(k) K890305

Name: FDA 510(k) clearance K890305
Creator: U.S. Food and Drug Administration
Published: 1989-02-17

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K890305 for BICARBONATE TEST ITEM NUMBER: SR1006, Substantially Equivalent on 1989-02-17. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1989-01-23
Decision date: 1989-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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