The following data is part of a premarket notification filed by Accumed Intl., Inc. with the FDA for Sensititre 18-24 Hour Susceptibility Plates With Trovafloxacin.
| Device ID | K983301 |
| 510k Number | K983301 |
| Device Name: | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1998-11-25 |