The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Marathon 6k General-purpose Centrifuge.
Device ID | K915825 |
510k Number | K915825 |
Device Name: | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE |
Classification | Instrument, Hematocrit, Automated |
Applicant | FISHER SCIENTIFIC CO., LLC. 1410 WAYNE AVE. Indiana, PA 15701 |
Contact | William O Clhishko |
Correspondent | William O Clhishko 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 | 1991-12-30 |
Decision Date | 1992-03-11 |