Cleared Traditional

PRECISET DAT AMPHETAMINE

K030826 · Quantimetrix Corp. · Toxicology

Apr 2003

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K030826 is an FDA 510(k) clearance for the PRECISET DAT AMPHETAMINE, a Lead, Delta Amino Levulinic Acid (Class II — Special Controls, product code DIJ), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on April 3, 2003, 20 days after receiving the submission on March 14, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3550.

Submission Details

510(k) Number	K030826 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2003
Decision Date	April 03, 2003
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF