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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K992086
Device Name OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
Original Applicant
OLYMPUS AMERICA, INC.
two corporate center dr.
melville,  NY  11747 -3157
Original Contact laura storms-tyler
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/21/1999
Decision Date 08/19/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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