Cleared Abbreviated

IRISPEC,CA/CB/CC

K072640 · Iris Diagnostics · Chemistry

Dec 2007

Decision

94d

Days

Class 1

Risk

About This 510(k) Submission

K072640 is an FDA 510(k) clearance for the IRISPEC,CA/CB/CC, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Iris Diagnostics (Chatsworth, US). The FDA issued a Cleared decision on December 21, 2007, 94 days after receiving the submission on September 18, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K072640 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2007
Decision Date	December 21, 2007
Days to Decision	94 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF