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FDA 510(k), K130122, BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
FDA 510(k), K130122, BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
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510(K) Number: K130122
Device Name: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
Manufacturer: BECKMAN COULTER, INC
Device Classification Name: Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation Number: 866.5510
Classification Product Code: CFN
Date Received: 01/17/2013
Decision Date: 01/07/2014
Regulation Medical Specialty: Immunology
Device Name: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
Manufacturer: BECKMAN COULTER, INC
Device Classification Name: Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation Number: 866.5510
Classification Product Code: CFN
Date Received: 01/17/2013
Decision Date: 01/07/2014
Regulation Medical Specialty: Immunology
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- Delivery: Approximately 1 to 2 weeks
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