The following data is part of a premarket notification filed by Greiner Bio-one Vacuette North America with the FDA for Vacuette Edta K3 Evacuated Blood Collection Tubes.
| Device ID | K042927 |
| 510k Number | K042927 |
| Device Name: | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES |
| Classification | Blood/plasma Collection Device For Dna Testing |
| Applicant | GREINER BIO-ONE VACUETTE NORTH AMERICA PO BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER BIO-ONE VACUETTE NORTH AMERICA PO BOX 103 Baldwin, MD 21013 |
| Product Code | PJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-22 |
| Decision Date | 2005-04-15 |
| Summary: | summary |