Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
FDA 510(k) clearance K173932 · decided 2018-01-26
Clearance details
- K-number
- K173932
- Device name
- Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
- Applicant
- Alere Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-26
- Decision date
- 2018-01-26
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- OCC
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.