PRJ · Class II · 21 CFR 862.1675

FDA Product Code PRJ: Capillary Blood Collection Device For Alternative Site Collection

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.

Leading manufacturers include Seventh Sense Biosystems, Inc..

Total

Cleared

266d

Avg days

2017

Since

FDA 510(k) Cleared Capillary Blood Collection Device For Alternative Site Collection Devices (Product Code PRJ)

2 devices

1–2 of 2

Cleared Nov 05, 2019

TAP Blood Collection Device

K190225

Seventh Sense Biosystems, Inc.

Chemistry · 273d

About Product Code PRJ - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all Chemistry FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Nov 05, 2019

Product Code Info

Code	PRJ
Device class	Class II
CFR	21 CFR 862.1675
Panel	Chemistry

Verify on FDA.gov

View PRJ classification on FDA.gov →