The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack.
| Device ID | K143651 |
| 510k Number | K143651 |
| Device Name: | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST Cypress, CA 90630 |
| Product Code | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101025576 | K143651 | 000 |
| 20816101025569 | K143651 | 000 |