Cleared Traditional

K061830 - STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
(FDA 510(k) Clearance)

K061830 · Nova Biomedical Corp. · Chemistry

Nov 2006

Decision

126d

Days

Class 2

Risk

K061830 is an FDA 510(k) clearance for the STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on November 1, 2006, 126 days after receiving the submission on June 28, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number	K061830 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2006
Decision Date	November 01, 2006
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement