The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre 20-24 Hour Haemophilus Influenzae/streptococcus Pneumoniae Mic Or Breakpoint Susceptibility System With Omadacycline In The Dilution Range Of 0.008 - 32 Ug/ml.
| Device ID | K183324 |
| 510k Number | K183324 |
| Device Name: | Sensititre 20-24 Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Omadacycline In The Dilution Range Of 0.008 - 32 Ug/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 | 2018-11-30 |
| Decision Date | 2019-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384571819 | K183324 | 000 |