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FDA 510(k)

ANA-5 AUTOANTIBODY PROFILE KIT

K-Number: K885224 · 1989-04-14

ApplicantAutoimmunity Diagnostics Corp.
Decision Date1989-04-14
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA-5 AUTOANTIBODY PROFILE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Autoimmunity Diagnostics Corp.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K885224. 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 ANA-5 AUTOANTIBODY PROFILE KIT?

ANA-5 AUTOANTIBODY PROFILE KIT is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Autoimmunity Diagnostics Corp.. The 510(k) number is K885224.

When did ANA-5 AUTOANTIBODY PROFILE KIT receive FDA 510(k) clearance?

ANA-5 AUTOANTIBODY PROFILE KIT received FDA 510(k) clearance on 1989-04-14, under 510(k) number K885224.

Who is the listed applicant for ANA-5 AUTOANTIBODY PROFILE KIT?

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

What is the FDA product code for ANA-5 AUTOANTIBODY PROFILE KIT?

The FDA product code for ANA-5 AUTOANTIBODY PROFILE KIT 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

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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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