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FDA 510(k)

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY

K-Number: K800820 · 1980-04-24

ApplicantCalbiochem-Behring Corp.
Decision Date1980-04-24
Product CodeDBE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY 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 1980-04-24 under 510(k) number K800820. The device is classified under product code DBE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY?

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K800820.

When did AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY receive FDA 510(k) clearance?

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800820.

Who is the listed applicant for AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY?

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 AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY?

The FDA product code for AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY is DBE.

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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: DBE)

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.

K810983ANTISMOOTH MUSCLE ANTIBODY TEST SYSImmuno-Products IndustriesK800228IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KITClinical Sciences, Inc.K790430MEDICA II-F-ASMA TEST KITMedica Corp.K771155ANTI-MITOCHONDRIALMeloy Laboratories, Inc.K760156TEST, (IVDP) SMOOTHMUSCLE ANTIBODYZeus Scientific, 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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