K030192 is an FDA 510(k) clearance for the DUET SYSTEM. This device is classified as a Device, Automated Cell-locating (Class II - Special Controls, product code JOY).
Submitted by Bioview , Ltd. (Ra'Ananna, IL). The FDA issued a Cleared decision on August 20, 2003, 211 days after receiving the submission on January 21, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5260.
| 510(k) Number | K030192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2003 |
| Decision Date | August 20, 2003 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOY — Device, Automated Cell-locating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5260 |