Newborn Screening Specimen Collection Paper

FDA product code PJC · Class II (moderate risk) · 21 CFR 862.1675 · Clinical Chemistry

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.

2510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K121864Perkinelmer 226 Sample Collection DevicesPJC · Abbreviated Perkinelmer, Inc.03/12/2013SE
K932661Whatman Body Fluid Collection Paper:Whatman BFC180PJC · Traditional Whatman Specialty Products, Inc.04/17/1996SE

Recalls

RecallProductFirmInitiated
Z-2264-2020 Class IIIPerkinElmer 226 Sample Collection DevicePerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels… PerkinElmer Health Sciences, Inc.12/19/2017Terminated
Z-2756-2017 Class IIIPerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is…PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels… PerkinElmer Health Sciences, Inc.05/31/2017Terminated
Z-1737-2017 Class IIBond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto…The product was marketed without 510(k) clearance. Agilent Technologies, Inc.06/17/2015Terminated