Cleared Traditional

ALPHA URINE SAMPLE

K900626 · Toxi-Lab, Inc. · Chemistry
Mar 1990
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K900626 is an FDA 510(k) clearance for the ALPHA URINE SAMPLE, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on March 6, 1990, 26 days after receiving the submission on February 8, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K900626 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1990
Decision Date March 06, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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