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FDA 510(k)

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114

K-Number: K024218 · 2003-01-17

ApplicantBio-Rad
Decision Date2003-01-17
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K024218. 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 LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114?

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Bio-Rad. The 510(k) number is K024218.

When did LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 receive FDA 510(k) clearance?

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 received FDA 510(k) clearance on 2003-01-17, under 510(k) number K024218.

Who is the listed applicant for LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114?

The FDA product code for LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 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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