C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET— 510(k) K002651
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K002651 for C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET, Substantially Equivalent on 2000-10-13. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
Recent devices under product code DCK
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