The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Hgb/glc Whole Blood Control.
| Device ID | K993321 |
| 510k Number | K993321 |
| Device Name: | R&D HGB/GLC WHOLE BLOOD CONTROL |
| Classification | Control, Hemoglobin |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021022 | K993321 | 000 |
| 00815762021015 | K993321 | 000 |
| 20815762020999 | K993321 | 000 |
| 20815762020975 | K993321 | 000 |
| 20815762020951 | K993321 | 000 |