DeviceClearance

Product code PRJ— Clinical Chemistry

TAP Blood Collection Device

Classification name
Capillary Blood Collection Device For Alternative Site Collection
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PRJ under 21 CFR 862.1675, via openFDA

Market context for product code PRJ

FDA has cleared 2 devices under product code PRJ between 2017 and 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PRJ

Recent clearances under product code PRJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.