The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Vacuette Blood Collection Tube With Lithium Heparin And Gel Separator.
| Device ID | K103041 |
| 510k Number | K103041 |
| Device Name: | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2010-11-09 |
| Summary: | summary |