VARELISA SM ANTIBODIES— 510(k) K000312
Substantially EquivalentPharmacia & Upjohn Co.
FDA 510(k) clearance K000312 for VARELISA SM ANTIBODIES, Substantially Equivalent on 2000-03-17. Applicant: Pharmacia & Upjohn Co.. Device class: 2.
Clearance details
- Applicant
- Pharmacia & Upjohn Co.
- Product code
- Code LKP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westervillle, OH, US
Recent devices under product code LKP
view allMore clearances from Pharmacia & Upjohn Co.
view all- K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES,
- K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
- 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
- K993388 — ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
Data sourced from openFDA. This site is unofficial and independent of the FDA.