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 Dtest (containing Erythromycin At 1 Ug/ml And Clindamycin At 0.5 Ug/ml).
| Device ID | K202612 |
| 510k Number | K202612 |
| Device Name: | Sensititre 20-24 Hour Haemophilus Influenzae /Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Dtest (containing Erythromycin At 1 Ug/mL And Clindamycin At 0.5 Ug/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village, OH 44146 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp Thermo Fisher Scientific One Thermo Fisher Way Oakwood Village, OH 44146 |
| 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 | 2020-09-09 |
| Decision Date | 2021-07-23 |