Access Thyroglobulin Antibody II
K-Number: K240996 · 2024-07-03
ApplicantBeckman Coulter, Inc.
Decision Date2024-07-03
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Access Thyroglobulin Antibody II is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-07-03 under approval number K240996. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Thyroglobulin Antibody II?
Access Thyroglobulin Antibody II is a medical device that received FDA 510(k) clearance on 2024-07-03. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240996.
When was Access Thyroglobulin Antibody II approved by the FDA?
Access Thyroglobulin Antibody II received FDA 510(k) clearance on 2024-07-03, under approval number K240996.
What company makes Access Thyroglobulin Antibody II?
Access Thyroglobulin Antibody II is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Thyroglobulin Antibody II?
The FDA product code for Access Thyroglobulin Antibody II is JNL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.