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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 K961510
Device Name ACS FRT4 IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
17392 DAIMLER ST.
IRVINE,  CA  92714
Applicant Contact THOMAS F FLYNN
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
17392 DAIMLER ST.
IRVINE,  CA  92714
Correspondent Contact THOMAS F FLYNN
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
CEC  
Date Received04/19/1996
Decision Date 06/17/1996
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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