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FDA 510(k)

ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA

K-Number: K971835 · 1997-07-03

ApplicantMonobind
Decision Date1997-07-03
Product CodeDDC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971835. The device is classified under product code DDC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA?

ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Monobind. The 510(k) number is K971835.

When did ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA receive FDA 510(k) clearance?

ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971835.

Who is the listed applicant for ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA?

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

What is the FDA product code for ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA?

The FDA product code for ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA is DDC.

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Other records listing Monobind as applicant

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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971921PROLACTIN (PRL) HORMONE MICROPLATE ELISA

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Related Devices (Code: DDC)

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.

K023592SERAQUEST ANTI-THYROGLOBULINQuest Intl., Inc.K012208ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895Beckman Coulter, Inc.K000363MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.K991610ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.Zeus Scientific, Inc.K991179ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.K953066SERODIA ATGFujirebio America, 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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