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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K042924
Device Name ARCHITECT STAT MYO 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 Number866.5680
Classification Product Code
DDR  
Subsequent Product Code
JIS  
Date Received10/22/2004
Decision Date 01/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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