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PJCClass II

Newborn Screening Specimen Collection Paper

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

PJC is the FDA product code for Newborn Screening Specimen Collection Paper, a class II device type, regulated under 21 CFR 862.1675. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PJC
Device name
Newborn Screening Specimen Collection Paper
FDA 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.
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
3

Clearances, product code PJC

By decision year
2 clearances under product code PJC with a decision year between 1996 and 2013, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PJC by decision year
YearClearances
19961
20131

Applicants with the most clearances

Product code PJC
Applicants holding the most 510(k) clearances under product code PJC
ApplicantClearances
Revvity Health Sciences, Inc.1
Whatman Specialty Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code