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FDA 510(k)

ANTISMOOTH MUSCLE ANTIBODY TEST SYS

K-Number: K810983 · 1981-05-01

ApplicantImmuno-Products Industries
Decision Date1981-05-01
Product CodeDBE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISMOOTH MUSCLE ANTIBODY TEST SYS is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Products Industries. It received FDA 510(k) clearance on 1981-05-01 under 510(k) number K810983. 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 ANTISMOOTH MUSCLE ANTIBODY TEST SYS?

ANTISMOOTH MUSCLE ANTIBODY TEST SYS is a medical device that received FDA 510(k) clearance on 1981-05-01. The listed applicant is Immuno-Products Industries. The 510(k) number is K810983.

When did ANTISMOOTH MUSCLE ANTIBODY TEST SYS receive FDA 510(k) clearance?

ANTISMOOTH MUSCLE ANTIBODY TEST SYS received FDA 510(k) clearance on 1981-05-01, under 510(k) number K810983.

Who is the listed applicant for ANTISMOOTH MUSCLE ANTIBODY TEST SYS?

The FDA 510(k) record lists Immuno-Products Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTISMOOTH MUSCLE ANTIBODY TEST SYS?

The FDA product code for ANTISMOOTH MUSCLE ANTIBODY TEST SYS is DBE.

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Other records listing Immuno-Products Industries 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.

K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDK852230ANA/LITE-RL TEST SYSTEMK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCP

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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.

K800820AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODYCalbiochem-Behring Corp.K800228IMMUNOP. 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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