Cleared Traditional

K843565 - KOVA TROL I,II, III HUMAN URINE-DRIED
(FDA 510(k) Clearance)

K843565 · Icl Scientific · Chemistry

Oct 1984

Decision

25d

Days

Class 1

Risk

K843565 is an FDA 510(k) clearance for the KOVA TROL I,II, III HUMAN URINE-DRIED, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984, 25 days after receiving the submission on September 10, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K843565 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 1984
Decision Date	October 05, 1984
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—