Cleared Traditional

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM

K950073 · Shared Systems, Inc. · Microbiology

Oct 1995

Decision

281d

Days

Class 1

Risk

About This 510(k) Submission

K950073 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM, a Antisera, All Mycoplasma Spp. (Class I — General Controls, product code GSA), submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on October 17, 1995, 281 days after receiving the submission on January 9, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number	K950073 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 09, 1995
Decision Date	October 17, 1995
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement