COLLOID OSMOMETER 4400

Osmometer For Clinical Use

WESCOR, INC.

The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Colloid Osmometer 4400.

Pre-market Notification Details

Device IDK834208
510k NumberK834208
Device Name:COLLOID OSMOMETER 4400
ClassificationOsmometer For Clinical Use
Applicant WESCOR, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJM  
CFR Regulation Number862.2730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-05
Decision Date1984-03-23

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