The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Densichek Plus.
| Device ID | K083536 |
| 510k Number | K083536 |
| Device Name: | DENSICHEK PLUS |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Jolyn Tenllado |
| Correspondent | Jolyn Tenllado 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 | 2008-11-28 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026222239 | K083536 | 000 |
| 03573026222222 | K083536 | 000 |