Cleared Traditional

K832783 - MICRO-SAMPLE OSMOMETER 3M0
(FDA 510(k) Clearance)

K832783 · Advanced Instruments, Inc. · Chemistry
Nov 1983
Decision
104d
Days
Class 1
Risk

K832783 is an FDA 510(k) clearance for the MICRO-SAMPLE OSMOMETER 3M0, a Osmometer For Clinical Use (Class I — General Controls, product code JJM), submitted by Advanced Instruments, Inc.. The FDA issued a Cleared decision on November 28, 1983, 104 days after receiving the submission on August 16, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2730.

Submission Details

510(k) Number K832783 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1983
Decision Date November 28, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

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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