K904675 is an FDA 510(k) clearance for the QBC SYSTEM MCHC. This device is classified as a Red-cell Indices, Calculated (Class II - Special Controls, product code JPJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on November 2, 1990, 21 days after receiving the submission on October 12, 1990.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5300.
| 510(k) Number | K904675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1990 |
| Decision Date | November 02, 1990 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPJ — Red-cell Indices, Calculated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5300 |