The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Sedrite Plus Erythrocyte Sedimentation Rate.
| Device ID | K991876 |
| 510k Number | K991876 |
| Device Name: | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE |
| 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 | 1999-06-02 |
| Decision Date | 1999-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021428 | K991876 | 000 |
| 00868556000239 | K991876 | 000 |
| 00868556000246 | K991876 | 000 |
| 00868556000253 | K991876 | 000 |
| 00815762021336 | K991876 | 000 |
| 00815762021343 | K991876 | 000 |
| 00815762021398 | K991876 | 000 |
| 00815762021404 | K991876 | 000 |
| 00815762021411 | K991876 | 000 |
| 00868556000215 | K991876 | 000 |