The following data is part of a premarket notification filed by Greiner Vacuette North America, Inc. with the FDA for Blood Specimen Collection Devices - Vacuum.
| Device ID | BK040066 |
| 510k Number | BK040066 |
| Device Name: | Blood Specimen Collection Devices - Vacuum |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Greiner Vacuette North America, Inc. 4238 Capital Dr Monroe, NC 28110 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 | 2004-08-18 |
| Decision Date | 2004-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049208556 | BK040066 | 000 |
| 39120017573341 | BK040066 | 000 |
| 39120017573556 | BK040066 | 000 |
| 39120017575413 | BK040066 | 000 |
| 39120017575499 | BK040066 | 000 |
| 39120017575512 | BK040066 | 000 |
| 39120017575765 | BK040066 | 000 |
| 39120017576694 | BK040066 | 000 |
| 39120017576700 | BK040066 | 000 |
| 39120017577059 | BK040066 | 000 |
| 39120017573303 | BK040066 | 000 |
| 39120017573068 | BK040066 | 000 |
| 39120017572894 | BK040066 | 000 |
| 39120049208563 | BK040066 | 000 |
| 39120049208181 | BK040066 | 000 |
| 39120049208198 | BK040066 | 000 |
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| 39120017572795 | BK040066 | 000 |
| 39120017579138 | BK040066 | 000 |
| 39120017579596 | BK040066 | 000 |
| 39120017579756 | BK040066 | 000 |
| 39120049204640 | BK040066 | 000 |
| 39120049204657 | BK040066 | 000 |
| 39120049204695 | BK040066 | 000 |
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| 39120049206835 | BK040066 | 000 |
| 39120049206842 | BK040066 | 000 |
| 39120049206859 | BK040066 | 000 |
| 39120049206866 | BK040066 | 000 |
| 39120049204626 | BK040066 | 000 |
| 39120049204619 | BK040066 | 000 |
| 39120049204602 | BK040066 | 000 |
| 39120049200192 | BK040066 | 000 |
| 39120049200437 | BK040066 | 000 |
| 39120049201830 | BK040066 | 000 |
| 39120049204473 | BK040066 | 000 |
| 39120049204480 | BK040066 | 000 |
| 39120049204497 | BK040066 | 000 |
| 39120049204503 | BK040066 | 000 |
| 39120049204541 | BK040066 | 000 |
| 39120049204596 | BK040066 | 000 |
| 39120049207733 | BK040066 | 000 |