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FDA 510(k)

THYROSCREEN TM T4 DIAGNOSTIC KIT

K-Number: K770474 · 1977-04-28

ApplicantAbbott Laboratories
Decision Date1977-04-28
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROSCREEN TM T4 DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-04-28 under 510(k) number K770474. 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 THYROSCREEN TM T4 DIAGNOSTIC KIT?

THYROSCREEN TM T4 DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1977-04-28. The listed applicant is Abbott Laboratories. The 510(k) number is K770474.

When did THYROSCREEN TM T4 DIAGNOSTIC KIT receive FDA 510(k) clearance?

THYROSCREEN TM T4 DIAGNOSTIC KIT received FDA 510(k) clearance on 1977-04-28, under 510(k) number K770474.

Who is the listed applicant for THYROSCREEN TM T4 DIAGNOSTIC KIT?

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

What is the FDA product code for THYROSCREEN TM T4 DIAGNOSTIC KIT?

The FDA product code for THYROSCREEN TM T4 DIAGNOSTIC KIT 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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