The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Marathon 13k/h Microhematocrit Centrifuge.
| Device ID | K915441 |
| 510k Number | K915441 |
| Device Name: | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | FISHER SCIENTIFIC CO., LLC. 1410 WAYNE AVE. Indiana, PA 15701 |
| Contact | William Chishko |
| Correspondent | William Chishko FISHER SCIENTIFIC CO., LLC. 1410 WAYNE AVE. Indiana, PA 15701 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-04 |
| Decision Date | 1992-01-08 |