The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R & D Systems Xeret Hematology Control.
Device ID | K100050 |
510k Number | K100050 |
Device Name: | R & D SYSTEMS XERET HEMATOLOGY CONTROL |
Classification | Mixture, Hematology Quality Control |
Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
Contact | Nancy Ring |
Correspondent | Nancy Ring 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 | 2010-01-08 |
Decision Date | 2010-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661003878 | K100050 | 000 |
00847661003861 | K100050 | 000 |
00847661003854 | K100050 | 000 |
00847661003847 | K100050 | 000 |