UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH— 510(k) K964152
Substantially EquivalentPharmacia, Inc.
FDA 510(k) clearance K964152 for UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH, Substantially Equivalent on 1997-04-23. Applicant: Pharmacia, Inc.. Device class: 2.
Clearance details
- Applicant
- Pharmacia, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westervillle, OH, US
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