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510(k) K121864

PERKINELMER 226 SAMPLE COLLECTION DEVICES by Perkinelmer, Inc. — Product Code PJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2013
Date Received
June 26, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Newborn Screening Specimen Collection Paper
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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.

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Other clearances for product code PJC

  • K932661 — WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (April 17, 1996)