The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre 18-24 Hour Mic Or Breakpoint Susceptibility System With Eravacycline In The Dilution Range Of 0.008- 16 µg/ml.
| Device ID | K182797 |
| 510k Number | K182797 |
| Device Name: | Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Eravacycline In The Dilution Range Of 0.008- 16 µg/mL |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44014 6 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44014 6 |
| Product Code | JWY |
| Subsequent Product Code | LRG |
| Subsequent Product Code | LTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2018-11-30 |