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FDA 510(k), K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
FDA 510(k), K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
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510(K) Number: K121214
Device Name: ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Manufacturer:
Device Classification Name: Immunoassay Method, Troponin Subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 04/23/2012
Decision Date: 06/14/2013
Regulation Medical Specialty: Clinical Chemistry
Device Name: ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Manufacturer:
Device Classification Name: Immunoassay Method, Troponin Subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 04/23/2012
Decision Date: 06/14/2013
Regulation Medical Specialty: Clinical Chemistry
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