DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM— 510(k) K012797
Substantially EquivalentDiamedix Corp.
FDA 510(k) clearance K012797 for DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM, Substantially Equivalent on 2001-09-28. Applicant: Diamedix Corp.. Device class: 2.
Clearance details
- Applicant
- Diamedix Corp.
- 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
- Miami, FL, US
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More clearances from Diamedix Corp.
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