COBAS CK-NAC REAGENT— 510(k) K801299

Name: FDA 510(k) clearance K801299
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Roche Analytical Instruments, Inc.

FDA 510(k) clearance K801299 for COBAS CK-NAC REAGENT, Substantially Equivalent on 1980-07-14. Applicant: Roche Analytical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Roche Analytical Instruments, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1980-06-02
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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