FDA 510(k)

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

K-Number: K082759 · 2009-04-10

Decision Date2009-04-10

Product CodeLKJ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2009-04-10 under 510(k) number K082759. 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 ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY?

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2009-04-10. The listed applicant is Phadia US, Inc.. The 510(k) number is K082759.

When did ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY receive FDA 510(k) clearance?

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY received FDA 510(k) clearance on 2009-04-10, under 510(k) number K082759.

Who is the listed applicant for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY?

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

What is the FDA product code for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY?

The FDA product code for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY is LKJ.

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Other records listing Phadia US, Inc. as applicant

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLE K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

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Related Devices (Code: LKJ)

K210902EliA Ro52, EliA Ro60Phadia AB K113610ANA-SCREEN WITH MDSSBio-Rad Laboratories K081104AESKULISA ANA HEP-2, REF 30-7115USAesku Diagnostics K041658BIOPLEX 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.K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001Corgenix, 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.