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 Dalbavancin (0.0005 - 2ug/ml).
| Device ID | K150236 |
| 510k Number | K150236 |
| Device Name: | Sensititre 18 - 24 Hour MIC Or Breakpoint Susceptibility System With Dalbavancin (0.0005 - 2ug/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 |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384571635 | K150236 | 000 |
| 05032384571802 | K150236 | 000 |