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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 K984323
Device Name ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/03/1998
Decision Date 12/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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