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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K922046
Device Name LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
Applicant
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Applicant Contact TEVA C ROTHWELL
Correspondent
Bio-Rad
3726 E. Miraloma Ave.
Anaheim,  CA  92806
Correspondent Contact TEVA C ROTHWELL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/01/1992
Decision Date 07/10/1992
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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