The following data is part of a premarket notification filed by Plaza Medical, Inc. with the FDA for Microhematocrit Centrifuge.
| Device ID | K864039 |
| 510k Number | K864039 |
| Device Name: | MICROHEMATOCRIT CENTRIFUGE |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | PLAZA MEDICAL, INC. 9780 EAST GIRARD DENVER, CO 80231 |
| Contact | RICE, JR |
| Correspondent | RICE, JR PLAZA MEDICAL, INC. 9780 EAST GIRARD DENVER, CO 80231 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-16 |
| Decision Date | 1986-10-29 |