ELECSYS CA 125 II— 510(k) K972162

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K972162 for ELECSYS CA 125 II, Substantially Equivalent on 1998-03-18. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1997-06-09
Decision date: 1998-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.