Cleared Abbreviated

PERKINELMER 226 SAMPLE COLLECTION DEVICES

K121864 · Perkinelmer, Inc. · Chemistry

Mar 2013

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K121864 is an FDA 510(k) clearance for the PERKINELMER 226 SAMPLE COLLECTION DEVICES, a Newborn Screening Specimen Collection Paper (Class II — Special Controls, product code PJC), submitted by Perkinelmer, Inc. (Greenville, US). The FDA issued a Cleared decision on March 12, 2013, 259 days after receiving the submission on June 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K121864 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2012
Decision Date	March 12, 2013
Days to Decision	259 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PJC — Newborn Screening Specimen Collection Paper
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1675
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.