IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02— 510(k) K052793
Substantially EquivalentPharmacia Diagnostics AB
FDA 510(k) clearance K052793 for IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02, Substantially Equivalent on 2006-02-07. Applicant: Pharmacia Diagnostics AB. Device class: 2.
Clearance details
- Applicant
- Pharmacia Diagnostics AB
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
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More clearances from Pharmacia Diagnostics AB
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