IMMUNOCAP ALLERGEN K82— 510(k) K121463
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K121463 for IMMUNOCAP ALLERGEN K82, Substantially Equivalent on 2013-01-29. Applicant: Thermo Fisher Scientific. Device class: 2.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- 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 K121463
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 K121463.
Data sourced from openFDA. This site is unofficial and independent of the FDA.