K834585 is an FDA 510(k) clearance for the CELLTRAK-B. This device is classified as a Device, Patient Transfer, Powered (Class II - Special Controls, product code FRZ).
Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984, 125 days after receiving the submission on December 29, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 880.6775.
| 510(k) Number | K834585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1983 |
| Decision Date | May 02, 1984 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | FRZ — Device, Patient Transfer, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6775 |