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FDA 510(k)

REAGENT, RIA TRIIODOTHYRONINE T3 (#200)

K-Number: K760078 · 1976-07-20

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

Device Summary

REAGENT, RIA TRIIODOTHYRONINE T3 (#200) 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 K760078. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT, RIA TRIIODOTHYRONINE T3 (#200)?

REAGENT, RIA TRIIODOTHYRONINE T3 (#200) 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 K760078.

When did REAGENT, RIA TRIIODOTHYRONINE T3 (#200) receive FDA 510(k) clearance?

REAGENT, RIA TRIIODOTHYRONINE T3 (#200) received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760078.

Who is the listed applicant for REAGENT, RIA TRIIODOTHYRONINE T3 (#200)?

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, RIA TRIIODOTHYRONINE T3 (#200)?

The FDA product code for REAGENT, RIA TRIIODOTHYRONINE T3 (#200) is CDP.

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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 DISPENSORK760144SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACIDK760148SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMANK760143SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANK760079REAGENT, THYROXINE T4 (#210)K760147SERUM, IGM ANTI-HUMAN ACID

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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