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FDA 510(k)

REAGENT SET, T-4, CPB

K-Number: K770737 · 1977-06-22

ApplicantG.D. Searle and Co.
Decision Date1977-06-22
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SET, T-4, CPB is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1977-06-22 under 510(k) number K770737. 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 REAGENT SET, T-4, CPB?

REAGENT SET, T-4, CPB is a medical device that received FDA 510(k) clearance on 1977-06-22. The listed applicant is G.D. Searle and Co.. The 510(k) number is K770737.

When did REAGENT SET, T-4, CPB receive FDA 510(k) clearance?

REAGENT SET, T-4, CPB received FDA 510(k) clearance on 1977-06-22, under 510(k) number K770737.

Who is the listed applicant for REAGENT SET, T-4, CPB?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT SET, T-4, CPB?

The FDA product code for REAGENT SET, T-4, CPB is CDX.

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Other records listing G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811068BYPASS COILK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SET

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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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