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 |