AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES— 510(k) K122197

Clearance details

Applicant

Phadia US, Inc.

Product code

Code DHB

Device class

Class 2

Regulation

21 CFR 866.5750

Advisory panel

Immunology

Date received

2012-07-24

Decision date

2013-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Portage, MI, US

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• K132631 — EIA SMDP IMMUNOASSAY2014-08-29
• K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY2013-12-23
• K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE2012-09-13

• Z-0947-2015 — Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.Class II·Terminated·Phadia US Inc·20141120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122197.