Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit— 510(k) K173653
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K173653 for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit, Substantially Equivalent on 2018-05-02. Applicant: Alere Scarborough, Inc..
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code PGX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Scarborough, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.