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FDA 510(k)

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST

K-Number: K852840 · 1985-08-01

ApplicantModern Diagnostics, Inc.
Decision Date1985-08-01
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Modern Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-08-01 under 510(k) number K852840. 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 ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST?

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST is a medical device that received FDA 510(k) clearance on 1985-08-01. The listed applicant is Modern Diagnostics, Inc.. The 510(k) number is K852840.

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

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST received FDA 510(k) clearance on 1985-08-01, under 510(k) number K852840.

Who is the listed applicant for ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST?

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

What is the FDA product code for ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST?

The FDA product code for ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST is LJM.

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Other records listing Modern 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.

K853269PREGNA/TESTK853258BETA-HCG MICROTITER PREGNANCY TESTK853006HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCYK851369ANTINUCLEAR ANTIBODY 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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