K053499 is an FDA 510(k) clearance for the HEMOSIL PROS. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).
Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on January 13, 2006, 28 days after receiving the submission on December 16, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K053499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2005 |
| Decision Date | January 13, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGP — Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |