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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K921089
Device Name LYPHOCHEK(R) FRUCTOSAMINE CONTROL
Applicant
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Applicant Contact DONNA CHAPMAN
Correspondent
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Correspondent Contact DONNA CHAPMAN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/06/1992
Decision Date 04/29/1992
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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