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DID — Bacillus Subtilis Microbiology Assay, Tobramycin Class II

FDA Device Classification

Classification Details

Product Code
DID
Device Class
Class II
Regulation Number
862.3900
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K820773syvaEMIT-ST URINE COCAINE METABOLITE ASSAYApril 8, 1982
K802038beckman instrumentsPHENYTOIN REAGENT TEST KITOctober 23, 1980
K780950monitor scienceBIO-MONITOR TOBRAMYCINAugust 14, 1978
K780182new england nuclearTOBRAMYCIN 125I RIA KITFebruary 13, 1978
K780048nichols institute diagnosticsAMINOGLYCOSIDE TEST SYSTEMJanuary 20, 1978