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FDA 510(k)

ANTINUCLEAR ANTIBODY TEST

K-Number: K872839 · 1987-10-20

ApplicantCappel Diagnostics, Inc.
Decision Date1987-10-20
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cappel Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K872839. 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 TEST?

ANTINUCLEAR ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Cappel Diagnostics, Inc.. The 510(k) number is K872839.

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

ANTINUCLEAR ANTIBODY TEST received FDA 510(k) clearance on 1987-10-20, under 510(k) number K872839.

Who is the listed applicant for ANTINUCLEAR ANTIBODY TEST?

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

What is the FDA product code for ANTINUCLEAR ANTIBODY TEST?

The FDA product code for ANTINUCLEAR ANTIBODY TEST 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 Cappel Diagnostics, 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.

K864275ANTI-NDNA ANTIBODY TEST KITK862821CAPPEL DIAGNOSTICS ANA 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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