The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Expresso Cartridge.
Device ID | K923316 |
510k Number | K923316 |
Device Name: | EXPRESSO CARTRIDGE |
Classification | Calculator/data Processing Module, For Clinical Use |
Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Joan Christenson |
Correspondent | Joan Christenson BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | JQP |
CFR Regulation Number | 862.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-07 |
Decision Date | 1993-02-23 |