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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K924692
Device Name OLYMPUS CREATININE 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 Number862.1225
Classification Product Code
CGX  
Date Received09/17/1992
Decision Date 10/19/1992
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
Recalls CDRH Recalls
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