IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2— 510(k) K963062

Name: FDA 510(k) clearance K963062
Creator: U.S. Food and Drug Administration
Published: 1996-12-13

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K963062 for IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2, Substantially Equivalent on 1996-12-13. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code KXT
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1996-08-07
Decision date: 1996-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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