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FDA 510(k)

T4 EIA BEAD ASSAY

K-Number: K920766 · 1992-04-17

ApplicantTech-Co, Inc.
Decision Date1992-04-17
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 EIA BEAD ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1992-04-17 under 510(k) number K920766. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T4 EIA BEAD ASSAY?

T4 EIA BEAD ASSAY is a medical device that received FDA 510(k) clearance on 1992-04-17. The listed applicant is Tech-Co, Inc.. The 510(k) number is K920766.

When did T4 EIA BEAD ASSAY receive FDA 510(k) clearance?

T4 EIA BEAD ASSAY received FDA 510(k) clearance on 1992-04-17, under 510(k) number K920766.

Who is the listed applicant for T4 EIA BEAD ASSAY?

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

What is the FDA product code for T4 EIA BEAD ASSAY?

The FDA product code for T4 EIA BEAD ASSAY is CDX.

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Other records listing Tech-Co, 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITYK883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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