Cleared Abbreviated

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

K032608 · Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · Chemistry

Oct 2003

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K032608 is an FDA 510(k) clearance for the GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB (Berlin, DE). The FDA issued a Cleared decision on October 21, 2003, 57 days after receiving the submission on August 25, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K032608 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2003
Decision Date	October 21, 2003
Days to Decision	57 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF