OSOM C. DIFFICILE TOXIN A/B TEST— 510(k) K102242
Substantially EquivalentGenzyme Corporation
FDA 510(k) clearance K102242 for OSOM C. DIFFICILE TOXIN A/B TEST, Substantially Equivalent on 2010-12-21. Applicant: Genzyme Corporation.
Clearance details
- Applicant
- Genzyme Corporation
- Product code
- Code LLH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Framingham, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.