COBAS-BIO CENTRIFUGAL ANALYZER— 510(k) K792671

Name: FDA 510(k) clearance K792671
Creator: U.S. Food and Drug Administration
Published: 1980-01-17

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K792671 for COBAS-BIO CENTRIFUGAL ANALYZER, Substantially Equivalent on 1980-01-17. Applicant: Hoffmann-La Roche, Inc.. Device class: 1.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code JJG
Device class: Class 1
Regulation: 21 CFR 862.2140
Advisory panel: Clinical Chemistry
Date received: 1979-12-27
Decision date: 1980-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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