K102552 is an FDA 510(k) clearance for the HEMOSIL LA POSITIVE CONTROL. This device is classified as a Control, Plasma, Abnormal (Class II - Special Controls, product code GGC).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on April 5, 2011, 210 days after receiving the submission on September 7, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K102552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2010 |
| Decision Date | April 05, 2011 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGC — Control, Plasma, Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |