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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Total Spinal-Fluid, Antigen, Antiserum, Control
510(k) Number K854190
Device Name CANTROL SPINAL FLUID CONTROL
Applicant
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Applicant Contact FALKOWSKI
Correspondent
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Correspondent Contact FALKOWSKI
Regulation Number866.5860
Classification Product Code
DFI  
Date Received10/15/1985
Decision Date 11/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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