ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3— 510(k) K982343
Substantially EquivalentPharmacia & Upjohn Co.
FDA 510(k) clearance K982343 for ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3, Substantially Equivalent on 1998-09-15. Applicant: Pharmacia & Upjohn Co.. Device class: 2.
Clearance details
- Applicant
- Pharmacia & Upjohn Co.
- 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
- Westervillle, OH, US
Recent devices under product code DHB
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- K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
- K000312 — VARELISA SM ANTIBODIES
- K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
- K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396
Data sourced from openFDA. This site is unofficial and independent of the FDA.