The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R & D Systems' Whole Blood Flow Control, (r & D - Wbfc).
| Device ID | K961610 |
| 510k Number | K961610 |
| Device Name: | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) |
| Classification | Counter, Differential Cell |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds, Ph.d. |
| Correspondent | Kenneth T Edds, Ph.d. R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-25 |
| Decision Date | 1996-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903497027 | K961610 | 000 |
| 00382903497010 | K961610 | 000 |
| 00382903497003 | K961610 | 000 |
| 00382903409136 | K961610 | 000 |
| 00382903409129 | K961610 | 000 |
| 00382903409112 | K961610 | 000 |