GONOCHEK II REAGENT TUBES— 510(k) K940162

Name: FDA 510(k) clearance K940162
Creator: U.S. Food and Drug Administration
Published: 1994-09-09

Substantially Equivalent

E-Y Laboratories, Inc.

FDA 510(k) clearance K940162 for GONOCHEK II REAGENT TUBES, Substantially Equivalent on 1994-09-09. Applicant: E-Y Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: E-Y Laboratories, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1994-01-12
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

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