CANTROL SPINAL FLUID CONTROL

Total Spinal-fluid, Antigen, Antiserum, Control

CANYON DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Spinal Fluid Control.

Pre-market Notification Details

Device IDK854190
510k NumberK854190
Device Name:CANTROL SPINAL FLUID CONTROL
ClassificationTotal Spinal-fluid, Antigen, Antiserum, Control
Applicant CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim,  CA  92807
ContactFalkowski
CorrespondentFalkowski
CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim,  CA  92807
Product CodeDFI  
CFR Regulation Number866.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-15
Decision Date1985-11-25

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