ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895— 510(k) K012208

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K012208 for ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895, Substantially Equivalent on 2001-09-07. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DDC
Advisory panel: Immunology
Date received: 2001-07-16
Decision date: 2001-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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