The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre Haemophilus / Streptococcus Pneumoniae (hp) Susceptibility Plates.
| Device ID | K133847 |
| 510k Number | K133847 |
| Device Name: | SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44146 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44146 |
| Product Code | JWY |
| 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 | 2013-12-18 |
| Decision Date | 2014-08-01 |