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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K924691
Device Name OLYMPUS IRON 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 Number862.1410
Classification Product Code
JIY  
Date Received09/17/1992
Decision Date 12/18/1992
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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