K893984 is an FDA 510(k) clearance for the HGB-CAL SET/MULTIPLE. This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 15, 1989, 71 days after receiving the submission on June 5, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K893984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1989 |
| Decision Date | August 15, 1989 |
| Days to Decision | 71 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 |