GLIADIN IGA AND GLIADIN LGA— 510(k) K113377
Substantially EquivalentGrifols USA, LLC
FDA 510(k) clearance K113377 for GLIADIN IGA AND GLIADIN LGA, Substantially Equivalent on 2012-12-14. Applicant: Grifols USA, LLC. Device class: 2.
Clearance details
- Applicant
- Grifols USA, LLC
- 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
- Los Angeles, CA, US
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More clearances from Grifols USA, LLC
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