K923316 is an FDA 510(k) clearance for the EXPRESSO CARTRIDGE. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 23, 1993, 231 days after receiving the submission on July 7, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K923316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1992 |
| Decision Date | February 23, 1993 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQP — Calculator/data Processing Module, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2100 |