Cleared Traditional

URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE

K860143 · Reagent Laboratory, Inc. · Chemistry

Feb 1986

Decision

26d

Days

Class 1

Risk

About This 510(k) Submission

K860143 is an FDA 510(k) clearance for the URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE, a Electrode, Ion Selective (non-specified) (Class I — General Controls, product code JJP), submitted by Reagent Laboratory, Inc. (Louisville, US). The FDA issued a Cleared decision on February 10, 1986, 26 days after receiving the submission on January 15, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K860143 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1986
Decision Date	February 10, 1986
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—