The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Cbc-xe Hematology Control.
Device ID | K042094 |
510k Number | K042094 |
Device Name: | R&D CBC-XE HEMATOLOGY CONTROL |
Classification | Mixture, Hematology Quality Control |
Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
Contact | Ralph E Hogancamp |
Correspondent | Ralph E Hogancamp 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 | 2004-08-03 |
Decision Date | 2004-09-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815762020926 | K042094 | 000 |
00815762020919 | K042094 | 000 |
00815762020902 | K042094 | 000 |
00847661003694 | K042094 | 000 |
00847661003687 | K042094 | 000 |