The following data is part of a premarket notification filed by Greiner Bio-one Gmbh with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK030001 |
| 510k Number | BK030001 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Greiner Bio-One GmbH 4238 Capital Drive Monroe, NC 28112 US |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049201847 | BK030001 | 000 |
| 39120017571293 | BK030001 | 000 |
| 39120017571422 | BK030001 | 000 |
| 39120017571484 | BK030001 | 000 |
| 39120017571705 | BK030001 | 000 |
| 39120017571859 | BK030001 | 000 |
| 39120017571873 | BK030001 | 000 |
| 39120017571934 | BK030001 | 000 |
| 39120017571989 | BK030001 | 000 |
| 39120017571996 | BK030001 | 000 |
| 39120017572061 | BK030001 | 000 |
| 39120017575680 | BK030001 | 000 |
| 39120017576366 | BK030001 | 000 |
| 39120017576403 | BK030001 | 000 |
| 39120017576410 | BK030001 | 000 |
| 39120017576441 | BK030001 | 000 |
| 39120017576496 | BK030001 | 000 |
| 39120017576502 | BK030001 | 000 |
| 39120017570852 | BK030001 | 000 |