The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Esr Control-m Hematology Erythrocyte Sedimentation.
| Device ID | K972172 |
| 510k Number | K972172 |
| Device Name: | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Sue Gallo |
| Correspondent | Sue Gallo 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-07-24 |
| Summary: | summary |