ALERE I STREP A— 510(k) K141757
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K141757 for ALERE I STREP A, Substantially Equivalent on 2015-03-31. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Product code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.