Cleared Traditional

K801391 - DISC 120 TRANSPORTER
(FDA 510(k) Clearance)

K801391 · Travenol Laboratories, S.A. · Immunology device

Jul 1980

Decision

31d

Days

Class 1

Risk

K801391 is an FDA 510(k) clearance for the DISC 120 TRANSPORTER. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980, 31 days after receiving the submission on June 13, 1980.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.

Submission Details

510(k) Number	K801391 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 13, 1980
Decision Date	July 14, 1980
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—