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FDA 510(k)

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB

K-Number: K843613 · 1984-10-31

ApplicantImmuno-Products Industries
Decision Date1984-10-31
Product CodeGMS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB 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 1984-10-31 under 510(k) number K843613. The device is classified under product code GMS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCENT TREPONEMEL ANTIBODY-ABSORB?

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Immuno-Products Industries. The 510(k) number is K843613.

When did FLUORESCENT TREPONEMEL ANTIBODY-ABSORB receive FDA 510(k) clearance?

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB received FDA 510(k) clearance on 1984-10-31, under 510(k) number K843613.

Who is the listed applicant for FLUORESCENT TREPONEMEL ANTIBODY-ABSORB?

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 FLUORESCENT TREPONEMEL ANTIBODY-ABSORB?

The FDA product code for FLUORESCENT TREPONEMEL ANTIBODY-ABSORB is GMS.

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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 SYSTEMK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCPK821576ANTINUCLEAR ANTIBODY SCREEN FLOURESC

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Related Devices (Code: GMS)

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 ABSORPEDImmuno-Products IndustriesK781403FTA-ABS TEST SYSTEMZeus 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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