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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 K002196
Device Name LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/20/2000
Decision Date 08/07/2000
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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