K031359 is an FDA 510(k) clearance for the S-MONOVETTE EDTA K2-GEL. This device is classified as a Blood/plasma Collection Device For Dna Testing (Class II - Special Controls, product code PJE).
Submitted by Sarstedt, Inc. (Newton, US). The FDA issued a Cleared decision on September 12, 2003, 135 days after receiving the submission on April 30, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675. A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing..
| 510(k) Number | K031359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2003 |
| Decision Date | September 12, 2003 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | PJE — Blood/plasma Collection Device For Dna Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna Testing. |