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FDA 510(k)

ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST

K-Number: K810984 · 1981-05-01

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

Device Summary

ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST 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 K810984. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST?

ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST 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 K810984.

When did ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST receive FDA 510(k) clearance?

ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST received FDA 510(k) clearance on 1981-05-01, under 510(k) number K810984.

Who is the listed applicant for ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST?

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 ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST?

The FDA product code for ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST is DBM.

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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: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, 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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