PRJ — Capillary Blood Collection Device For Alternative Site Collection Class II
FDA product code PRJ covers "Capillary Blood Collection Device For Alternative Site Collection", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PRJ
- Device Class
- Class II
- Regulation Number
- 862.1675
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.