The following data is part of a premarket notification filed by Biomerieux with the FDA for Vidas H. Pylori Igg, Vidas 3, Vidas Lyme Igg Ii, Vidas Rub Igg, Vidas Toxo M, Vidas Human Chorionic Gonadotropin, Vidas T4, Vidas Testosterone, Vidas Tsh, And Vidas D-dimer Exclusion Ii.
| Device ID | K141133 |
| 510k Number | K141133 |
| Device Name: | VIDAS H. Pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, And VIDAS D-Dimer Exclusion II |
| Classification | Helicobacter Pylori |
| Applicant | BIOMERIEUX 595 ANGLUM ROAD Hazelwood, MO 63042 -2320 |
| Contact | John Albright |
| Correspondent | John Albright BIOMERIEUX 595 ANGLUM ROAD Hazelwood, MO 63042 -2320 |
| Product Code | LYR |
| Subsequent Product Code | CDZ |
| Subsequent Product Code | DAP |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| Subsequent Product Code | KLI |
| Subsequent Product Code | LFX |
| Subsequent Product Code | LGD |
| Subsequent Product Code | LSR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026613839 | K141133 | 000 |
| 03573026380175 | K141133 | 000 |
| 03573026377427 | K141133 | 000 |
| 03573026608866 | K141133 | 000 |
| 03573026474317 | K141133 | 000 |
| 03573026156916 | K141133 | 000 |
| 03573026156923 | K141133 | 000 |
| 03573026617622 | K141133 | 000 |