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510(k) K032608

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER by Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB — Product Code JIS

K032608 is an FDA 510(k) premarket notification submitted by Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB for the device "GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER". The FDA issued a decision of Substantially Equivalent on October 21, 2003. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2003
Date Received
August 25, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)
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