CBI 7520 READER— 510(k) K961183

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K961183 for CBI 7520 READER, Substantially Equivalent on 1996-08-02. Applicant: Columbia Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1996-03-26
Decision date: 1996-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.