The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Platelet Centrifuge.
| Device ID | K822715 |
| 510k Number | K822715 |
| Device Name: | PLATELET CENTRIFUGE |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | BIODYNAMICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1982-09-30 |