Cleared Traditional

Continuous Single Culture -NX (CSCM-NX)

K170681 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Jun 2017
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K170681 is an FDA 510(k) clearance for the Continuous Single Culture -NX (CSCM-NX), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 8, 2017, 94 days after receiving the submission on March 6, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K170681 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2017
Decision Date June 08, 2017
Days to Decision 94 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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