MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL— 510(k) K802934

Name: FDA 510(k) clearance K802934
Creator: U.S. Food and Drug Administration
Published: 1980-12-31

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K802934 for MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL, Substantially Equivalent on 1980-12-31. Applicant: Orion Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GSB
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1980-11-19
Decision date: 1980-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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