Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device
FDA 510(k) K011673 · ACON Laboratories, Inc.
510(k) numberK011673
Submission
- Device name
- Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- May 30, 2001
- Decision date
- July 31, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device cleared by the FDA?
Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device (K011673) received a 510(k) decision of Substantially Equivalent on July 31, 2001, 62 days after the submission was received.
What is the product code of K011673?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.