OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071— 510(k) K043460

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K043460 for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071, Substantially Equivalent on 2005-01-31. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2004-12-15
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Irving, TX, US

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