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FDA 510(k)

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

K-Number: K914853 · 1992-01-15

ApplicantReads Medical Products, Inc.
Decision Date1992-01-15
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reads Medical Products, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K914853. 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 ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT?

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Reads Medical Products, Inc.. The 510(k) number is K914853.

When did ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914853.

Who is the listed applicant for ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT?

The FDA 510(k) record lists Reads Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT?

The FDA product code for ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT is LJM.

Related Clinical Trials

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.

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Other records listing Reads Medical Products, Inc. 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.

K914405READS(R) IGA ANTI-CARDIOLIPIN TEST KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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