The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Systems Tetic-i Plus Hemotology Control.
Device ID | K091433 |
510k Number | K091433 |
Device Name: | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY 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 | 2009-05-13 |
Decision Date | 2009-10-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661004981 | K091433 | 000 |
00847661004974 | K091433 | 000 |
00847661004967 | K091433 | 000 |
00847661004950 | K091433 | 000 |