ELECSYS FSH ASSAY— 510(k) K964693

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964693 for ELECSYS FSH ASSAY, Substantially Equivalent on 1996-12-16. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1996-11-22
Decision date: 1996-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.