K041905 is an FDA 510(k) clearance for the HEMOSIL CALIBRATION PLASMA. This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 28, 2004, 75 days after receiving the submission on July 15, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K041905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2004 |
| Decision Date | September 28, 2004 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |