PICSI SPERM SELECTION DEVICE— 510(k) K052457

Substantially Equivalent

Biocoat, Inc.

FDA 510(k) clearance K052457 for PICSI SPERM SELECTION DEVICE, Substantially Equivalent on 2006-04-13. Applicant: Biocoat, Inc.. Device class: 2.

Clearance details

Applicant: Biocoat, Inc.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2005-09-07
Decision date: 2006-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, 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.