The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Glu-line Hematology Control.
Device ID | K034048 |
510k Number | K034048 |
Device Name: | R&D GLU-LINE HEMATOLOGY CONTROL |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
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 | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-30 |
Decision Date | 2004-03-10 |
Summary: | summary |