Cleared Traditional

K905493 - MERISTAR-MP
(FDA 510(k) Clearance)

K905493 · Meridian Diagnostics, Inc. · Microbiology

Jan 1991

Decision

54d

Days

Class 1

Risk

K905493 is an FDA 510(k) clearance for the MERISTAR-MP. This device is classified as a Antisera, All Mycoplasma Spp. (Class I — General Controls, product code GSA).

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 30, 1991, 54 days after receiving the submission on December 7, 1990.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number	K905493 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 1990
Decision Date	January 30, 1991
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—