IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS— 510(k) K111919
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K111919 for IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS, Substantially Equivalent on 2011-12-22. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Product code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code DHB
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view all- K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
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- K132631 — EIA SMDP IMMUNOASSAY
- K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
- K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.