Cleared Traditional

CONTINUOUS SINGLE CULTURE COMPLETE

K121572 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Jul 2012
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K121572 is an FDA 510(k) clearance for the CONTINUOUS SINGLE CULTURE COMPLETE, 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 July 19, 2012, 51 days after receiving the submission on May 29, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K121572 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2012
Decision Date July 19, 2012
Days to Decision 51 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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