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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 K070640
Device Name ARCHITECT STAT TROPONIN-1; MYOGLOBIN
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE, PO BX 307
MIDDLETOWN,  VA  22645
Applicant Contact HEATHER CAMERON
Correspondent
FISHER DIAGNOSTICS
8365 VALLEY PIKE, PO BX 307
MIDDLETOWN,  VA  22645
Correspondent Contact HEATHER CAMERON
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
DDR  
Date Received03/07/2007
Decision Date 09/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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