BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010— 510(k) K083744
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K083744 for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010, Substantially Equivalent on 2009-09-01. Applicant: Binax, Inc.. Device class: 1.
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code MJZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
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