The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-plt-4 Whole Blood Control/multiple.
| Device ID | K843962 |
| 510k Number | K843962 |
| Device Name: | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Dale A Christensen |
| Correspondent | Dale A Christensen 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 | 1984-10-11 |
| Decision Date | 1984-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600833 | K843962 | 000 |
| 00847661004943 | K843962 | 000 |
| 00847661004936 | K843962 | 000 |
| 06944904084145 | K843962 | 000 |