K030964 is an FDA 510(k) clearance for the CALIBRATION PLASMA LMW HEPARIN. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on June 6, 2003, 71 days after receiving the submission on March 27, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K030964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2003 |
| Decision Date | June 06, 2003 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |