FDA 510(k)

T4 BY RIA DIAG. KIT

K-Number: K771414 · 1977-09-22

Decision Date1977-09-22

Product CodeCDX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

T4 BY RIA DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Labs., Inc.. It received FDA 510(k) clearance on 1977-09-22 under 510(k) number K771414. 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 BY RIA DIAG. KIT?

T4 BY RIA DIAG. KIT is a medical device that received FDA 510(k) clearance on 1977-09-22. The listed applicant is Biomedical Labs., Inc.. The 510(k) number is K771414.

When did T4 BY RIA DIAG. KIT receive FDA 510(k) clearance?

T4 BY RIA DIAG. KIT received FDA 510(k) clearance on 1977-09-22, under 510(k) number K771414.

Who is the listed applicant for T4 BY RIA DIAG. KIT?

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

What is the FDA product code for T4 BY RIA DIAG. KIT?

The FDA product code for T4 BY RIA DIAG. KIT is CDX.

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 OY K934384AXSYM(TM) TOTAL T4Abbott Laboratories K932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.