PJC · Class II · 21 CFR 862.1675

FDA Product Code PJC: Newborn Screening Specimen Collection Paper

Newborn Screening Specimen Collection Paper Is A Blood Collection Device Intended To Be Used As Medium To Collect And Transport Whole Blood Specimens From Newborns To The Laboratory For In Vitro Diagnostic Analysis.

Leading manufacturers include Perkinelmer, Inc. and Whatman Specialty Products, Inc..

2
Total
2
Cleared
655d
Avg days
1996
Since

FDA 510(k) Cleared Newborn Screening Specimen Collection Paper Devices (Product Code PJC)

2 devices
1–2 of 2
Cleared Mar 12, 2013
PERKINELMER 226 SAMPLE COLLECTION DEVICES
K121864
Perkinelmer, Inc.
Chemistry · 259d
Cleared Apr 17, 1996
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
K932661
Whatman Specialty Products, Inc.
Chemistry · 1050d

About Product Code PJC - Regulatory Context