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FDA 510(k)

SERA-TEK THYROGLOBULIN ANTIBODY TEST

K-Number: K865020 · 1987-02-02

ApplicantMiles Laboratories, Inc.
Decision Date1987-02-02
Product CodeDDC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERA-TEK THYROGLOBULIN ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K865020. 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 SERA-TEK THYROGLOBULIN ANTIBODY TEST?

SERA-TEK THYROGLOBULIN ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K865020.

When did SERA-TEK THYROGLOBULIN ANTIBODY TEST receive FDA 510(k) clearance?

SERA-TEK THYROGLOBULIN ANTIBODY TEST received FDA 510(k) clearance on 1987-02-02, under 510(k) number K865020.

Who is the listed applicant for SERA-TEK THYROGLOBULIN ANTIBODY TEST?

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

What is the FDA product code for SERA-TEK THYROGLOBULIN ANTIBODY TEST?

The FDA product code for SERA-TEK THYROGLOBULIN ANTIBODY TEST is DDC.

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Other records listing Miles Laboratories, Inc. as applicant

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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.K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAMonobind

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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