BinaxNOW G6PD Test— 510(k) K161364
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K161364 for BinaxNOW G6PD Test, Substantially Equivalent on 2016-06-17. Applicant: Alere Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code JBF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7360
- Advisory panel
- Hematology
- 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.