The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa Influenza A H1n1 (2009) Model Mol2500.
| Device ID | K100148 |
| 510k Number | K100148 |
| Device Name: | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
| Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST. Cypress, CA 90630 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST. Cypress, CA 90630 |
| Product Code | OQW |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025521 | K100148 | 000 |