The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Plt - 4 Platelet.
| Device ID | K840302 |
| 510k Number | K840302 |
| Device Name: | PLT - 4 PLATELET |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-12 |