Cleared Traditional

HEMOCHEK URINE COLLECTION KIT

K991800 · Osborn Group, Inc. · Chemistry

Sep 1999

Decision

121d

Days

Class 1

Risk

About This 510(k) Submission

K991800 is an FDA 510(k) clearance for the HEMOCHEK URINE COLLECTION KIT, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Osborn Group, Inc. (Olathe, US). The FDA issued a Cleared decision on September 24, 1999, 121 days after receiving the submission on May 26, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K991800 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 1999
Decision Date	September 24, 1999
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1645