K013708 is an FDA 510(k) clearance for the REFERENCE CHECK, CATALOG NUMBER-RCN-10. This device is classified as a Plasma, Control, Normal (Class II - Special Controls, product code GIZ).
Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on December 10, 2001, 32 days after receiving the submission on November 8, 2001.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K013708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2001 |
| Decision Date | December 10, 2001 |
| Days to Decision | 32 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 |