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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K880496
Device Name LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Applicant Contact FRANK MATARRESE
Correspondent
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Correspondent Contact FRANK MATARRESE
Regulation Number862.1660
Classification Product Code
JJW  
Date Received02/04/1988
Decision Date 03/16/1988
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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