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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K923412
Device Name OLYMPUS LACTATE DEHYDROGENASE REAGENT
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received07/10/1992
Decision Date 09/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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