K003328 is an FDA 510(k) clearance for the ACCUCLOT CONTROL I, MODEL A4089. This device is classified as a Plasma, Control, Normal (Class II - Special Controls, product code GIZ).
Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 1, 2001, 128 days after receiving the submission on October 24, 2000.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K003328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2000 |
| Decision Date | March 01, 2001 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIZ — Plasma, Control, Normal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |