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 |