Cleared Traditional

URITEST 9, INLAB REAGENT STRIPS URINALY

K822709 · Laprol Scientific, Inc. · Chemistry
Jan 1983
Decision
143d
Days
Class 1
Risk

About This 510(k) Submission

K822709 is an FDA 510(k) clearance for the URITEST 9, INLAB REAGENT STRIPS URINALY, a Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) (Class I — General Controls, product code JMA), submitted by Laprol Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983, 143 days after receiving the submission on September 7, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1095.

Submission Details

510(k) Number K822709 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1982
Decision Date January 28, 1983
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMA — Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1095