AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES— 510(k) K121156
Substantially EquivalentPhadia AB
FDA 510(k) clearance K121156 for AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES, Substantially Equivalent on 2013-03-13. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- 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
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Recalls naming K121156
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121156.
Data sourced from openFDA. This site is unofficial and independent of the FDA.