ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)— 510(k) K062516

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K062516 for ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS), Substantially Equivalent on 2006-10-05. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JNL
Advisory panel: Immunology
Date received: 2006-08-28
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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