Cleared Traditional

K850841 - MOD THAYER MARTIN MARTIN LEWIS
(FDA 510(k) Clearance)

K850841 · Micro Media Laboratories · Microbiology

Mar 1985

Decision

19d

Days

Class 2

Risk

K850841 is an FDA 510(k) clearance for the MOD THAYER MARTIN MARTIN LEWIS. This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II — Special Controls, product code JTY).

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985, 19 days after receiving the submission on March 1, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number	K850841 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1985
Decision Date	March 20, 1985
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—