The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for S-monovette Edta K2-gel.
| Device ID | K031359 |
| 510k Number | K031359 |
| Device Name: | S-MONOVETTE EDTA K2-GEL |
| Classification | Blood/plasma Collection Device For Dna Testing |
| Applicant | SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Contact | Peter Rumswinkel |
| Correspondent | Peter Rumswinkel SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. Newton, NC 28658 |
| Product Code | PJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-09-12 |