The following data is part of a premarket notification filed by Genesis Bps, Llc with the FDA for Transfer Sets.
| Device ID | BK140187 |
| 510k Number | BK140187 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Genesis BPS, 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 | 2014-10-21 |
| Decision Date | 2015-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866305000202 | BK140187 | 0 |
| 10866305000254 | BK140187 | 0 |
| 10866305000247 | BK140187 | 0 |
| 10866305000230 | BK140187 | 0 |