TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30— 510(k) K082210
Substantially EquivalentGenzyme Diagnostics P.E.I., Inc.
FDA 510(k) clearance K082210 for TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30, Substantially Equivalent on 2008-12-16. Applicant: Genzyme Diagnostics P.E.I., Inc.. Device class: 2.
Clearance details
- Applicant
- Genzyme Diagnostics P.E.I., Inc.
- 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
- Traditional
- Location
- Charlottetown, Prin Ed Island, CA
Recent devices under product code CIG
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