K964689 is an FDA 510(k) clearance for the TRACCELL 2000 SLIDE MAPPING SYSTEM. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by Accumed Intl., Inc. (Chicago, US). The FDA issued a Cleared decision on August 18, 1997, 269 days after receiving the submission on November 22, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K964689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1996 |
| Decision Date | August 18, 1997 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JOY — Device, Automated Cell-locating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5260 |