Cleared Traditional

K802934 - MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
(FDA 510(k) Clearance)

K802934 · Orion Diagnostica, Inc. · Microbiology

Dec 1980

Decision

42d

Days

Class 1

Risk

K802934 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL. This device is classified as a Antigens, Cf, All, Mycoplasma Spp. (Class I — General Controls, product code GSB).

Submitted by Orion Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 42 days after receiving the submission on November 19, 1980.

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

Submission Details

510(k) Number	K802934 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1980
Decision Date	December 31, 1980
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—