CEDIA DIGOXIN CALIBRATORS— 510(k) K972433

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K972433 for CEDIA DIGOXIN CALIBRATORS, Substantially Equivalent on 1997-07-24. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant
Boehringer Mannheim Corp.
Product code
Code DLJ
Device class
Class 2
Regulation
21 CFR 862.3200
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, CA, US
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