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FDA 510(k)

ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)

K-Number: K883883 · 1988-10-27

ApplicantImmco Diagnostics, Inc.
Decision Date1988-10-27
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-10-27 under 510(k) number K883883. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)?

ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) is a medical device that received FDA 510(k) clearance on 1988-10-27. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K883883.

When did ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) received FDA 510(k) clearance on 1988-10-27, under 510(k) number K883883.

Who is the listed applicant for ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)?

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

What is the FDA product code for ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)?

The FDA product code for ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) is LKJ.

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Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II 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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