Cleared Traditional

K840974 - SOMAS HUMAN SPINAL FLUID CONTROL
(FDA 510(k) Clearance)

K840974 · Somas Medical Industries, Inc. · Immunology device

Apr 1984

Decision

30d

Days

Class 1

Risk

K840974 is an FDA 510(k) clearance for the SOMAS HUMAN SPINAL FLUID CONTROL. This device is classified as a Total Spinal-fluid, Antigen, Antiserum, Control (Class I - General Controls, product code DFI).

Submitted by Somas Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 30 days after receiving the submission on March 6, 1984.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5860.

Submission Details

510(k) Number	K840974 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 06, 1984
Decision Date	April 05, 1984
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—