PRJ

Capillary Blood Collection Device For Alternative Site Collection

Product code

PRJ

Device name

Capillary Blood Collection Device For Alternative Site Collection

Device class

Class 2

21 CFR

21 CFR 862.1675

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).