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FDA 510(k)

TRIIODOTHYRONINE RADIOIMMUN. SYSTEM

K-Number: K801123 · 1980-06-09

ApplicantCalbiochem-Behring Corp.
Decision Date1980-06-09
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIIODOTHYRONINE RADIOIMMUN. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801123. 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 TRIIODOTHYRONINE RADIOIMMUN. SYSTEM?

TRIIODOTHYRONINE RADIOIMMUN. SYSTEM is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K801123.

When did TRIIODOTHYRONINE RADIOIMMUN. SYSTEM receive FDA 510(k) clearance?

TRIIODOTHYRONINE RADIOIMMUN. SYSTEM received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801123.

Who is the listed applicant for TRIIODOTHYRONINE RADIOIMMUN. SYSTEM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIIODOTHYRONINE RADIOIMMUN. SYSTEM?

The FDA product code for TRIIODOTHYRONINE RADIOIMMUN. SYSTEM is CDP.

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Other records listing Calbiochem-Behring Corp. 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.

K831811REVOLUTION RADIAL IMMUNODIFFUSION PLATEK831036ENA TEST KIT SM & RNP AUTO ANTIBODYK830214AFT SYSTEM IIIK820812CREATINE KINASE-MB KITK813493ENZYGNOST TM RUBELLA IGMK820088AFT SYSTEM PROFICIENCY TESTING PROGRAM

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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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