ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY— 510(k) K940005

Name: FDA 510(k) clearance K940005
Creator: U.S. Food and Drug Administration
Published: 1994-03-03

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K940005 for ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY, Substantially Equivalent on 1994-03-03. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1994-01-03
Decision date: 1994-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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