Phadia Prime— 510(k) K151029
Substantially EquivalentPhadia AB
FDA 510(k) clearance K151029 for Phadia Prime, Substantially Equivalent on 2016-01-19. 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
- Special
- Location
- Uppsala, SE
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Recalls naming K151029
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 K151029.
Data sourced from openFDA. This site is unofficial and independent of the FDA.