Preciset Dat Amphetamine

FDA 510(k) K030826 · Quantimetrix Corp.

Substantially Equivalent

510(k) numberK030826

Submission

Device name
Preciset Dat Amphetamine
Applicant
Quantimetrix Corp.
Redondo Beach, CA, US
Received
March 14, 2003
Decision date
April 3, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DIJ – Lead, Delta Amino Levulinic Acid
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3550
Specialty
Clinical Toxicology

Other 510(k)s with product code DIJ

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Questions and answers

When was Preciset Dat Amphetamine cleared by the FDA?

Preciset Dat Amphetamine (K030826) received a 510(k) decision of Substantially Equivalent on April 3, 2003, 20 days after the submission was received.

What is the product code of K030826?

The FDA product code is DIJ – Lead, Delta Amino Levulinic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3550.