ALERE PBP2A SA/CONS CULTURE COLONY TEST— 510(k) K133851
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K133851 for ALERE PBP2A SA/CONS CULTURE COLONY TEST, Substantially Equivalent on 2014-09-03. Applicant: Alere Scarborough, Inc..
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code MYI
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.