The following data is part of a premarket notification filed by Greiner Bio-one Vacuette North America with the FDA for Vacuette Evacuated Blood Collection Tubes.
| Device ID | K011699 |
| 510k Number | K011699 |
| Device Name: | VACUETTE EVACUATED BLOOD COLLECTION TUBES |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-01 |
| Decision Date | 2001-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017579886 | K011699 | 000 |
| 39120017579862 | K011699 | 000 |
| 39120017573983 | K011699 | 000 |
| 39120017573938 | K011699 | 000 |
| 39120017573907 | K011699 | 000 |