ALERE PBP2A TEST— 510(k) K121905
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K121905 for ALERE PBP2A TEST, Substantially Equivalent on 2012-07-26. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code MYI
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.