DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3— 510(k) K002174
Substantially EquivalentCasco-Nerl Diagnostics Corporation (Maine)
FDA 510(k) clearance K002174 for DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3, Substantially Equivalent on 2000-08-22. Applicant: Casco-Nerl Diagnostics Corporation (Maine). Device class: 1.
Clearance details
- Applicant
- Casco-Nerl Diagnostics Corporation (Maine)
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
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More clearances from Casco-Nerl Diagnostics Corporation (Maine)
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