GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM— 510(k) K002189
Substantially EquivalentScimedx Corp.
FDA 510(k) clearance K002189 for GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM, Substantially Equivalent on 2000-10-19. Applicant: Scimedx Corp.. Device class: 2.
Clearance details
- Applicant
- Scimedx 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
- Denvill, NJ, US
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More clearances from Scimedx Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.