The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Bc-5d Hematology Control.
| Device ID | K160606 |
| 510k Number | K160606 |
| Device Name: | BC-5D Hematology Control |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY ST NE Minneapolis, MN 55413 |
| Contact | Ravi Kommineni |
| Correspondent | Rachel Somsen R & D SYSTEMS, INC. 614 MCKINLEY ST NE 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 | 2016-03-02 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904084169 | K160606 | 000 |