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FDA 510(k)

TBG DIAGNOSTIC KIT

K-Number: K811725 · 1981-07-10

ApplicantImmuno Assay Corp.
Decision Date1981-07-10
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TBG DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811725. The device is classified under product code CEF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBG DIAGNOSTIC KIT?

TBG DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Immuno Assay Corp.. The 510(k) number is K811725.

When did TBG DIAGNOSTIC KIT receive FDA 510(k) clearance?

TBG DIAGNOSTIC KIT received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811725.

Who is the listed applicant for TBG DIAGNOSTIC KIT?

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

What is the FDA product code for TBG DIAGNOSTIC KIT?

The FDA product code for TBG DIAGNOSTIC KIT is CEF.

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Other records listing Immuno Assay Corp. 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820089TSH (RIA) KITK820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811213T3 (RIA) KIT

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Related Devices (Code: CEF)

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.

K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebiaK972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-RadK964453REP 3 FLUR SPE-60 KITHelena LaboratoriesK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMorax

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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