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

Name: FDA 510(k) clearance K062516
Creator: U.S. Food and Drug Administration
Published: 2006-10-05

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.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JNL
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2006-08-28
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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