Cleared Traditional

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)

K902155 · Hichem Diagnostics · Chemistry
Jun 1990
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K902155 is an FDA 510(k) clearance for the HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964), a Method, Metallic Reduction, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIM), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on June 12, 1990, 28 days after receiving the submission on May 15, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K902155 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1990
Decision Date June 12, 1990
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIM — Method, Metallic Reduction, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340