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PJC — Newborn Screening Specimen Collection Paper Class II

FDA Device Classification

Classification Details

Product Code
PJC
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121864perkinelmerPERKINELMER 226 SAMPLE COLLECTION DEVICESMarch 12, 2013
K932661whatman specialty productsWHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180April 17, 1996