REFLOTRON POTASSIUM TEST TABS— 510(k) K904033

Name: FDA 510(k) clearance K904033
Creator: U.S. Food and Drug Administration
Published: 1990-11-06

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K904033 for REFLOTRON POTASSIUM TEST TABS, Substantially Equivalent on 1990-11-06. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1990-08-31
Decision date: 1990-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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