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FDA 510(k), K112177, SOFIA ANALYZER AND INFLUENZA A+B FIA
FDA 510(k), K112177, SOFIA ANALYZER AND INFLUENZA A+B FIA
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510(K) Number: K112177
Device Name: SOFIA ANALYZER AND INFLUENZA A+B FIA
Manufacturer: JOHN D TAMERIUS
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 07/28/2011
Decision Date: 10/24/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: SOFIA ANALYZER AND INFLUENZA A+B FIA
Manufacturer: JOHN D TAMERIUS
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 07/28/2011
Decision Date: 10/24/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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