VARELISA TPO ANTIBODIES, MODEL 12348/12396— 510(k) K993585
Substantially EquivalentPharmacia & Upjohn Co.
FDA 510(k) clearance K993585 for VARELISA TPO ANTIBODIES, MODEL 12348/12396, Substantially Equivalent on 2000-01-05. Applicant: Pharmacia & Upjohn Co.. Device class: 2.
Clearance details
- Applicant
- Pharmacia & Upjohn Co.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westervillle, OH, US
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