EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT— 510(k) K080823
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K080823 for EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT, Substantially Equivalent on 2008-11-17. Applicant: Medica Corp.. Device class: 2.
Clearance details
- Applicant
- Medica Corp.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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