The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Cutter/compur Mini Centrifuge.
Device ID | K781059 |
510k Number | K781059 |
Device Name: | CUTTER/COMPUR MINI CENTRIFUGE |
Classification | Instrument, Hematocrit, Automated |
Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKF |
CFR Regulation Number | 864.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-26 |
Decision Date | 1978-08-14 |