EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200— 510(k) K091991
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K091991 for EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200, Substantially Equivalent on 2009-09-04. Applicant: Medica Corp.. Device class: 2.
Clearance details
- Applicant
- Medica Corp.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
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