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FDA 510(k)

TOTAL THYROXINE (RIA) REAGENT SET

K-Number: K770940 · 1977-06-22

ApplicantThe Dow Chemical Co.
Decision Date1977-06-22
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL THYROXINE (RIA) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1977-06-22 under 510(k) number K770940. 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 TOTAL THYROXINE (RIA) REAGENT SET?

TOTAL THYROXINE (RIA) REAGENT SET is a medical device that received FDA 510(k) clearance on 1977-06-22. The listed applicant is The Dow Chemical Co.. The 510(k) number is K770940.

When did TOTAL THYROXINE (RIA) REAGENT SET receive FDA 510(k) clearance?

TOTAL THYROXINE (RIA) REAGENT SET received FDA 510(k) clearance on 1977-06-22, under 510(k) number K770940.

Who is the listed applicant for TOTAL THYROXINE (RIA) REAGENT SET?

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

What is the FDA product code for TOTAL THYROXINE (RIA) REAGENT SET?

The FDA product code for TOTAL THYROXINE (RIA) REAGENT SET is CDX.

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Other records listing The Dow Chemical 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATION

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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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