REFLOTRON BILIRUBIN— 510(k) K872818

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K872818 for REFLOTRON BILIRUBIN, Substantially Equivalent on 1987-11-23. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1987-07-16
Decision date: 1987-11-23
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.