EASYRA GLU-H REAGENT, MODEL 10200— 510(k) K092506
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K092506 for EASYRA GLU-H REAGENT, MODEL 10200, Substantially Equivalent on 2009-09-16. Applicant: Medica Corp.. Device class: 2.
Clearance details
- Applicant
- Medica Corp.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
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