FERTILMARQ TEST KIT— 510(k) K983473

Name: FDA 510(k) clearance K983473
Creator: U.S. Food and Drug Administration
Published: 1998-12-17

Substantially Equivalent

Embryotech Laboratories, Inc.

FDA 510(k) clearance K983473 for FERTILMARQ TEST KIT, Substantially Equivalent on 1998-12-17. 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: 1998-10-02
Decision date: 1998-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

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