Continuous Single Culture -NX (CSCM-NX)— 510(k) K170681

Name: FDA 510(k) clearance K170681
Creator: U.S. Food and Drug Administration
Published: 2017-06-08

Substantially Equivalent

Irvine Scientific Sales Co., Inc.

FDA 510(k) clearance K170681 for Continuous Single Culture -NX (CSCM-NX), Substantially Equivalent on 2017-06-08. Applicant: Irvine Scientific Sales Co., Inc.. Device class: 2.

Clearance details

Applicant: Irvine Scientific Sales Co., Inc.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2017-03-06
Decision date: 2017-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.