Cleared Traditional

EXPRESSO CARTRIDGE

K923316 · Bio-Rad Laboratories, Inc. · Chemistry
Feb 1993
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K923316 is an FDA 510(k) clearance for the EXPRESSO CARTRIDGE, 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 review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K923316 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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