The following data is part of a premarket notification filed by Genesisbps, Llc with the FDA for Set, Transfer (blood/plasma).
| Device ID | BK210584 |
| 510k Number | BK210584 |
| Device Name: | Set, Transfer (Blood/Plasma) |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | GenesisBPS, LLC 465 State Route 17 Ramsey, NJ 07446 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-22 |
| Decision Date | 2022-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866305000264 | BK210584 | 0 |