MRSASELECT - EXTENDED INCUBATION— 510(k) K081212
Substantially EquivalentBio-Rad
FDA 510(k) clearance K081212 for MRSASELECT - EXTENDED INCUBATION, Substantially Equivalent on 2008-06-13. Applicant: Bio-Rad.
Clearance details
- Applicant
- Bio-Rad
- Product code
- Code JSO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Adverse events under product code JSO
product code JSO- Malfunction
- 602
- Total
- 602
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.