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FDA 510(k)

ANA/LITE-RL TEST SYSTEM

K-Number: K852230 · 1985-07-10

ApplicantImmuno-Products Industries
Decision Date1985-07-10
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA/LITE-RL TEST SYSTEM 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 1985-07-10 under 510(k) number K852230. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA/LITE-RL TEST SYSTEM?

ANA/LITE-RL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-10. The listed applicant is Immuno-Products Industries. The 510(k) number is K852230.

When did ANA/LITE-RL TEST SYSTEM receive FDA 510(k) clearance?

ANA/LITE-RL TEST SYSTEM received FDA 510(k) clearance on 1985-07-10, under 510(k) number K852230.

Who is the listed applicant for ANA/LITE-RL TEST SYSTEM?

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 ANA/LITE-RL TEST SYSTEM?

The FDA product code for ANA/LITE-RL TEST SYSTEM is LJM.

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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 ABSORPEDK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCPK821576ANTINUCLEAR ANTIBODY SCREEN FLOURESC

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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