The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Sensititre Susceptibility Plates.
Device ID | K923045 |
510k Number | K923045 |
Device Name: | SENSITITRE SUSCEPTIBILITY PLATES |
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 | 1992-06-24 |
Decision Date | 1993-03-09 |