COBAS REAGENT FOR BUN— 510(k) K801116

Name: FDA 510(k) clearance K801116
Creator: U.S. Food and Drug Administration
Published: 1980-06-17

Substantially Equivalent

Roche Analytical Instruments, Inc.

FDA 510(k) clearance K801116 for COBAS REAGENT FOR BUN, Substantially Equivalent on 1980-06-17. Applicant: Roche Analytical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Roche Analytical Instruments, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1980-05-12
Decision date: 1980-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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