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FDA 510(k)

REAGENT, THYROXINE T4 (#210)

K-Number: K760079 · 1976-07-20

ApplicantOxford Laboratories, Inc.
Decision Date1976-07-20
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, THYROXINE T4 (#210) is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Laboratories, Inc.. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760079. 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, THYROXINE T4 (#210)?

REAGENT, THYROXINE T4 (#210) is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Oxford Laboratories, Inc.. The 510(k) number is K760079.

When did REAGENT, THYROXINE T4 (#210) receive FDA 510(k) clearance?

REAGENT, THYROXINE T4 (#210) received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760079.

Who is the listed applicant for REAGENT, THYROXINE T4 (#210)?

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

What is the FDA product code for REAGENT, THYROXINE T4 (#210)?

The FDA product code for REAGENT, THYROXINE T4 (#210) is CDX.

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Other records listing Oxford Laboratories, Inc. 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.

K780912ADJUSTABLE DISPENSORK760148SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMANK760078REAGENT, RIA TRIIODOTHYRONINE T3 (#200)K760143SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANK760144SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACIDK760147SERUM, IGM ANTI-HUMAN ACID

View all 9 devices →

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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