FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT— 510(k) K862813

Name: FDA 510(k) clearance K862813
Creator: U.S. Food and Drug Administration
Published: 1986-09-16

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K862813 for FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT, Substantially Equivalent on 1986-09-16. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1986-07-24
Decision date: 1986-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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