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FDA 510(k)

ACCESS THYROGLOBULIN ANITBODY

K-Number: K112933 · 2011-12-27

ApplicantBeckman Coulter, Inc.
Decision Date2011-12-27
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACCESS THYROGLOBULIN ANITBODY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2011-12-27 under 510(k) number K112933. 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 ANITBODY?

ACCESS THYROGLOBULIN ANITBODY is a medical device that received FDA 510(k) clearance on 2011-12-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K112933.

When did ACCESS THYROGLOBULIN ANITBODY receive FDA 510(k) clearance?

ACCESS THYROGLOBULIN ANITBODY received FDA 510(k) clearance on 2011-12-27, under 510(k) number K112933.

Who is the listed applicant for ACCESS THYROGLOBULIN ANITBODY?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESS THYROGLOBULIN ANITBODY?

The FDA product code for ACCESS THYROGLOBULIN ANITBODY is JNL.

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Other records listing Beckman Coulter, Inc. as applicant

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K262109Access NT-proBNPK252169Access BNP IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgG

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Related Devices (Code: JNL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobindK962341HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)Hycor Biomedical, Inc.

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.

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