K041130 is an FDA 510(k) clearance for the CDS HEMATOLOGY CALIBRATOR (CDS CAL). This device is classified as a Calibrator For Hemoglobin And Hematocrit Measurement (Class II - Special Controls, product code KRZ).
Submitted by Clinical Diagnostic Solutions, Inc. (Plantation, US). The FDA issued a Cleared decision on June 10, 2004, 41 days after receiving the submission on April 30, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8165.
| 510(k) Number | K041130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2004 |
| Decision Date | June 10, 2004 |
| Days to Decision | 41 days |
| Submission Type | Abbreviated |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | KRZ — Calibrator For Hemoglobin And Hematocrit Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8165 |