Cleared Traditional

CANTROL SPINAL FLUID CONTROL

K854190 · Canyon Diagnostics, Inc. · Immunology
Nov 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K854190 is an FDA 510(k) clearance for the CANTROL SPINAL FLUID CONTROL, a Total Spinal-fluid, Antigen, Antiserum, Control (Class I — General Controls, product code DFI), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 25, 1985, 41 days after receiving the submission on October 15, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5860.

Submission Details

510(k) Number K854190 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFI — Total Spinal-fluid, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5860