Cleared Traditional

EMBRYO BIOPSY MEDIUM

K021358 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology
Jul 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K021358 is an FDA 510(k) clearance for the EMBRYO BIOPSY MEDIUM, 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 5, 2002, 67 days after receiving the submission on April 29, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K021358 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2002
Decision Date July 05, 2002
Days to Decision 67 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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