SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES— 510(k) K884528

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K884528 for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES, Substantially Equivalent on 1989-03-08. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1988-10-28
Decision date: 1989-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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