The following data is part of a premarket notification filed by Biomerieux with the FDA for Etest Tobramycin 0.016-256 Ug/ml And 0.064-1024 Ug/ml.
| Device ID | K102668 |
| 510k Number | K102668 |
| Device Name: | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BIOMERIEUX 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson BIOMERIEUX 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-16 |
| Decision Date | 2010-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026378875 | K102668 | 000 |
| 03573026253233 | K102668 | 000 |
| 03573026254490 | K102668 | 000 |
| 03573026250768 | K102668 | 000 |
| 03573026619565 | K102668 | 000 |
| 03573026624545 | K102668 | 000 |