FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY— 510(k) K011679

Name: FDA 510(k) clearance K011679
Creator: U.S. Food and Drug Administration
Published: 2001-08-15

Substantially Equivalent

Embryotech Laboratories, Inc.

FDA 510(k) clearance K011679 for FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY, Substantially Equivalent on 2001-08-15. Applicant: Embryotech Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Embryotech Laboratories, Inc.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2001-05-30
Decision date: 2001-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

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