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FDA 510(k)

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE

K-Number: K883765 · 1988-10-31

ApplicantBiotecx Laboratories, Inc.
Decision Date1988-10-31
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-31 under 510(k) number K883765. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE?

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K883765.

When did TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE receive FDA 510(k) clearance?

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE received FDA 510(k) clearance on 1988-10-31, under 510(k) number K883765.

Who is the listed applicant for TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE?

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

What is the FDA product code for TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE?

The FDA product code for TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE is KHQ.

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Other records listing Biotecx Laboratories, Inc. 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.

K982298OPTICOAT T4 EIA KITK981824OPTICOAT T3 EIA KITK895407CORTISOL CLASP-BEAD EIA KITK893620T3 CLASP-BEAD EIA KITK892853T4 CLASP-BEAD EIA KITK871211PROGESTERONE CLASP RADIOIMMUNOASSAY KIT

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer 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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