K100148 is an FDA 510(k) clearance for the SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500. This device is classified as a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II - Special Controls, product code OQW).
Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on May 24, 2010, 125 days after receiving the submission on January 19, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3332. 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens.
| 510(k) Number | K100148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2010 |
| Decision Date | May 24, 2010 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3332 |
| Definition | 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens |