GLIADIN ANTIBODIES ELISA— 510(k) K973910
Substantially EquivalentGenesis Diagnostics , Ltd.
FDA 510(k) clearance K973910 for GLIADIN ANTIBODIES ELISA, Substantially Equivalent on 1999-02-17. Applicant: Genesis Diagnostics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Genesis Diagnostics , Ltd.
- 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
- Littleport, Cambridgeshire, GB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.