Cleared Traditional

K854423 - IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
(FDA 510(k) Clearance)

K854423 · Dynatech Laboratories, Inc. · Microbiology

Nov 1985

Decision

15d

Days

Class 1

Risk

K854423 is an FDA 510(k) clearance for the IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES. This device is classified as a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB).

Submitted by Dynatech Laboratories, Inc. (Alexandria, US). The FDA issued a Cleared decision on November 20, 1985, 15 days after receiving the submission on November 5, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K854423 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1985
Decision Date	November 20, 1985
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—