Cleared Traditional

JAUNDICE METER, MODEL JM 103

K042522 · Draeger Medical Infant Care, Inc. · Chemistry

Jul 2005

Decision

293d

Days

Class 1

Risk

About This 510(k) Submission

K042522 is an FDA 510(k) clearance for the JAUNDICE METER, MODEL JM 103, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Draeger Medical Infant Care, Inc. (Hatboro, US). The FDA issued a Cleared decision on July 6, 2005, 293 days after receiving the submission on September 16, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number	K042522 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2004
Decision Date	July 06, 2005
Days to Decision	293 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF