The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Statusflow.
| Device ID | K982231 |
| 510k Number | K982231 |
| Device Name: | STATUSFLOW |
| Classification | Counter, Differential Cell |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-25 |
| Decision Date | 1998-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903497058 | K982231 | 000 |
| 00382903497041 | K982231 | 000 |
| 00382903497034 | K982231 | 000 |
| 00382903409167 | K982231 | 000 |
| 00382903409150 | K982231 | 000 |
| 00382903409143 | K982231 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STATUSFLOW 75134311 2107999 Live/Registered |
Research & Diagnostic Systems, Inc. 1996-07-15 |