SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500— 510(k) K100148
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K100148 for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500, Substantially Equivalent on 2010-05-24. Applicant: Focus Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- Product code
- Code OQW
- Device class
- Class 2
- Regulation
- 21 CFR 866.3332
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
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