K033775 is an FDA 510(k) clearance for the HEMOSIL LIQUID ANTITHROMBIN XL. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 2, 2004, 30 days after receiving the submission on December 3, 2003.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K033775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2003 |
| Decision Date | January 02, 2004 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |