FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT— 510(k) K862813

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..

Clearance details

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

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