OLYMPUS SERUM PROTEIN MULTICALIBRATOR,— 510(k) K981854

Name: FDA 510(k) clearance K981854
Creator: U.S. Food and Drug Administration
Published: 1998-08-18

Substantially Equivalent

Olympus Diagnostica GmbH

FDA 510(k) clearance K981854 for OLYMPUS SERUM PROTEIN MULTICALIBRATOR,, Substantially Equivalent on 1998-08-18. Applicant: Olympus Diagnostica GmbH. Device class: 2.

Clearance details

Applicant: Olympus Diagnostica GmbH
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1998-05-26
Decision date: 1998-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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