COBAS REAGENT FOR ALKALINE PHOSPHATASE— 510(k) K801242

Name: FDA 510(k) clearance K801242
Creator: U.S. Food and Drug Administration
Published: 1980-06-20

Substantially Equivalent

Roche Analytical Instruments, Inc.

FDA 510(k) clearance K801242 for COBAS REAGENT FOR ALKALINE PHOSPHATASE, Substantially Equivalent on 1980-06-20. Applicant: Roche Analytical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Roche Analytical Instruments, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1980-05-27
Decision date: 1980-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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