The following data is part of a premarket notification filed by Accumed Intl., Inc. with the FDA for Traccell 2000 Slide Mapping System.
| Device ID | K982786 |
| 510k Number | K982786 |
| Device Name: | TRACCELL 2000 SLIDE MAPPING SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | ACCUMED INTL., INC. 900 NO. FRANKLIN SUITE 401 Chicago, IL 60610 |
| Contact | Norman J Pressman |
| Correspondent | Norman J Pressman ACCUMED INTL., INC. 900 NO. FRANKLIN SUITE 401 Chicago, IL 60610 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-10-16 |