The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Laser Plateletcal/multiple.
| Device ID | K852016 |
| 510k Number | K852016 |
| Device Name: | LASER PLATELETCAL/MULTIPLE |
| Classification | Calibrator For Platelet Counting |
| 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 | KRY |
| CFR Regulation Number | 864.8175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-07-09 |