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 |