The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Qbc Centrifugal Hematology Control.
Device ID | K984099 |
510k Number | K984099 |
Device Name: | QBC CENTRIFUGAL HEMATOLOGY CONTROL |
Classification | Mixture, Hematology Quality Control |
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 | JPK |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-17 |
Decision Date | 1998-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858092006543 | K984099 | 000 |
00858092006277 | K984099 | 000 |