K843695 is an FDA 510(k) clearance for the QCA HEMOGLOBIN KIT. This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 17, 1984, 89 days after receiving the submission on September 19, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K843695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1984 |
| Decision Date | December 17, 1984 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KRZ — Calibrator For Hemoglobin And Hematocrit Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8165 |