The following data is part of a premarket notification filed by Heraeus-christ Gmbh with the FDA for Haemofuge A. Biofuge A. & B.
| Device ID | K840767 |
| 510k Number | K840767 |
| Device Name: | HAEMOFUGE A. BIOFUGE A. & B |
| Classification | Device, Hematocrit Measuring |
| Applicant | HERAEUS-CHRIST GMBH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPI |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-04-17 |