Cleared Traditional

INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

K941807 · Intersect Systems, Inc. · Chemistry

Sep 1994

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K941807 is an FDA 510(k) clearance for the INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT, a Acid, Phosphoric-tungstic (spectrophotometric), Chloride (Class II — Special Controls, product code CHG), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on September 14, 1994, 155 days after receiving the submission on April 12, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number	K941807 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 1994
Decision Date	September 14, 1994
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement