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FDA 510(k)

IN-VITRO TBG RADIOIMMUNOASSAY TEST

K-Number: K810967 · 1981-04-23

ApplicantClinical Assays, Inc.
Decision Date1981-04-23
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN-VITRO TBG RADIOIMMUNOASSAY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810967. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-VITRO TBG RADIOIMMUNOASSAY TEST?

IN-VITRO TBG RADIOIMMUNOASSAY TEST is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K810967.

When did IN-VITRO TBG RADIOIMMUNOASSAY TEST receive FDA 510(k) clearance?

IN-VITRO TBG RADIOIMMUNOASSAY TEST received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810967.

Who is the listed applicant for IN-VITRO TBG RADIOIMMUNOASSAY TEST?

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

What is the FDA product code for IN-VITRO TBG RADIOIMMUNOASSAY TEST?

The FDA product code for IN-VITRO TBG RADIOIMMUNOASSAY TEST is CEE.

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Other records listing Clinical Assays, Inc. as applicant

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K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832711VITAMIN B12 FOLATE CA-1515-125K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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Related Devices (Code: CEE)

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.

K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.

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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