Cleared Traditional

K051646 - ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
(FDA 510(k) Clearance)

K051646 · Pointe Scientific, Inc., · Chemistry

Oct 2005

Decision

108d

Days

Class 2

Risk

K051646 is an FDA 510(k) clearance for the ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 7, 2005, 108 days after receiving the submission on June 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K051646 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2005
Decision Date	October 07, 2005
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement