Cleared Traditional

ADVANCED MICRO-OSMOMETER MODEL 3300

K962056 · Advanced Instruments, Inc. · Chemistry
Jul 1996
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K962056 is an FDA 510(k) clearance for the ADVANCED MICRO-OSMOMETER MODEL 3300, 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 July 11, 1996, 44 days after receiving the submission on May 28, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2730.

Submission Details

510(k) Number K962056 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1996
Decision Date July 11, 1996
Days to Decision 44 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