CEDIA T4— 510(k) K915194

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K915194 for CEDIA T4, Substantially Equivalent on 1991-12-09. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1991-11-19
Decision date: 1991-12-09
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.