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FDA 510(k)

RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE

K-Number: K810351 · 1981-02-23

ApplicantEndocrine-Metabolic Center
Decision Date1981-02-23
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine-Metabolic Center. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K810351. 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 RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE?

RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K810351.

When did RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE receive FDA 510(k) clearance?

RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE received FDA 510(k) clearance on 1981-02-23, under 510(k) number K810351.

Who is the listed applicant for RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE?

The FDA 510(k) record lists Endocrine-Metabolic Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE?

The FDA product code for RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE is CDP.

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Other records listing Endocrine-Metabolic Center 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.

K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDK811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK800187EMC-M-175, THYROXINE - 100 TUBESK800188EMC-M-180, T3 UPTAKE - 100 TUBES

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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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