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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name immunoassay method, troponin subunit
510(k) Number K041192
Device Name ARCHITECT STAT TROPONIN-I IMMUNOASSAY
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE, PO BX 307
MIDDLETOWN,  VA  22645
Applicant Contact JOSEFINA INFANTAS
Correspondent
FISHER DIAGNOSTICS
8365 VALLEY PIKE, PO BX 307
MIDDLETOWN,  VA  22645
Correspondent Contact JOSEFINA INFANTAS
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
JIT  
Date Received05/06/2004
Decision Date 08/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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