DeviceClearance

Product code PJC— Clinical Chemistry

PERKINELMER 226 SAMPLE COLLECTION DEVICES

Classification name
Newborn Screening Specimen Collection Paper
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

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

Market context for product code PJC

FDA has cleared 2 devices under product code PJC between 1996 and 2013, filed by 2 applicant companies. 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 PJC

Recent clearances under product code PJC

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