UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82— 510(k) K972068
Substantially EquivalentPharmacia, Inc.
FDA 510(k) clearance K972068 for UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82, Substantially Equivalent on 1997-07-03. Applicant: Pharmacia, Inc.. Device class: 2.
Clearance details
- Applicant
- Pharmacia, Inc.
- 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
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