The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Sensititre Susceptibility Enterococcal Vanco Amp.
| Device ID | K944753 |
| 510k Number | K944753 |
| Device Name: | SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Laura K Basista |
| Correspondent | Laura K Basista RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-26 |
| Decision Date | 1995-02-24 |