Cleared Traditional

NANOSEP N10

K935496 · Intersep , Ltd. · Chemistry
Apr 1994
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K935496 is an FDA 510(k) clearance for the NANOSEP N10, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Intersep , Ltd. (England, GB). The FDA issued a Cleared decision on April 26, 1994, 162 days after receiving the submission on November 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number K935496 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1993
Decision Date April 26, 1994
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJH — Clinical Sample Concentrator
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2310