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FDA 510(k)

DATA-TOPE T4 RIA PROCEDURE

K-Number: K761282 · 1976-12-30

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1976-12-30
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-TOPE T4 RIA PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761282. 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 DATA-TOPE T4 RIA PROCEDURE?

DATA-TOPE T4 RIA PROCEDURE is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K761282.

When did DATA-TOPE T4 RIA PROCEDURE receive FDA 510(k) clearance?

DATA-TOPE T4 RIA PROCEDURE received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761282.

Who is the listed applicant for DATA-TOPE T4 RIA PROCEDURE?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATA-TOPE T4 RIA PROCEDURE?

The FDA product code for DATA-TOPE T4 RIA PROCEDURE is CDX.

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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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