FDA 510(k)

T4-RIA KIT

K-Number: K780707 · 1978-06-14

Decision Date1978-06-14

Product CodeCDX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

T4-RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Bioresearch. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780707. 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-RIA KIT?

T4-RIA KIT is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Clinical Bioresearch. The 510(k) number is K780707.

When did T4-RIA KIT receive FDA 510(k) clearance?

T4-RIA KIT received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780707.

Who is the listed applicant for T4-RIA KIT?

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

What is the FDA product code for T4-RIA KIT?

The FDA product code for T4-RIA KIT is CDX.

Other records listing Clinical Bioresearch 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.

K780499CBR-T3RIA KIT K780500CBR-T3 UPTAKE KIT K780498CBR-DIGOXIN ANTISERUM

Related Devices (Code: CDX)

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

View on FDA Database →

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