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FDA 510(k)

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

K-Number: K870968 · 1987-06-22

ApplicantCanadian Bioclinical, Ltd.
Decision Date1987-06-22
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Bioclinical, Ltd.. It received FDA 510(k) clearance on 1987-06-22 under 510(k) number K870968. 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 TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-06-22. The listed applicant is Canadian Bioclinical, Ltd.. The 510(k) number is K870968.

When did TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1987-06-22, under 510(k) number K870968.

Who is the listed applicant for TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Canadian Bioclinical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA product code for TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT is CDP.

Related Clinical Trials

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.

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Other records listing Canadian Bioclinical, Ltd. 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.

K933794ANI BIOCARD(TM) HCG TESTK870969CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KITK864449DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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