K014104 is an FDA 510(k) clearance for the VACUETTE EDTA K2 TUBES. This device is classified as a Blood/plasma Collection Device For Dna Testing (Class II - Special Controls, product code PJE).
Submitted by Greiner Vacuette North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on February 1, 2002, 50 days after receiving the submission on December 13, 2001.
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 | K014104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2001 |
| Decision Date | February 01, 2002 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| 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. |