Cleared Traditional

THE ADVANCED OSMOMETER (3900)

K965036 · Advanced Instruments, Inc. · Chemistry
Feb 1997
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K965036 is an FDA 510(k) clearance for the THE ADVANCED OSMOMETER (3900), a Osmometer For Clinical Use (Class I — General Controls, product code JJM), submitted by Advanced Instruments, Inc. (Norwood, US). The FDA issued a Cleared decision on February 20, 1997, 65 days after receiving the submission on December 17, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2730.

Submission Details

510(k) Number K965036 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1996
Decision Date February 20, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJM — Osmometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2730

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