The following data is part of a premarket notification filed by Biomerieux, Inc with the FDA for Vitek Densichek.
| Device ID | K192110 |
| 510k Number | K192110 |
| Device Name: | Vitek Densichek |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Jennifer Jines |
| Correspondent | Nathan Hardesty bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026607104 | K192110 | 000 |
| 03573026605667 | K192110 | 000 |
| 03573026605674 | K192110 | 000 |