510(k) K802934— MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
Substantially EquivalentOrion Diagnostica, Inc.
Clearance details
- Applicant
- Orion Diagnostica, Inc.
- Product code
- Code GSB
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.