ELECSYS FERRITIN— 510(k) K971833

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K971833 for ELECSYS FERRITIN, Substantially Equivalent on 1997-06-02. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1997-05-19
Decision date: 1997-06-02
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.