ELECSYS CALLCHECK DIGOXIN— 510(k) K973973

Name: FDA 510(k) clearance K973973
Creator: U.S. Food and Drug Administration
Published: 1997-11-04

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K973973 for ELECSYS CALLCHECK DIGOXIN, Substantially Equivalent on 1997-11-04. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DMP
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1997-10-20
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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