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Device Classification
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DKD — Bacillus Subtilis, Microbiological Assay, Gentamicin
Class II
FDA Device Classification
Classification Details
Product Code
DKD
Device Class
Class II
Regulation Number
862.3450
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K780951
monitor science
BIO-MONITOR GENTAMICIN
August 14, 1978
K760942
bd becton dickinson vacutainer systems preanalytic
GENTASAK
March 7, 1977