Acon Amp 300 One Step Amphetamine Test Strip and Device
FDA 510(k) K041822 · ACON Laboratories, Inc.
510(k) numberK041822
Submission
- Device name
- Acon Amp 300 One Step Amphetamine Test Strip and Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- July 6, 2004
- Decision date
- September 16, 2004
- 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 300 One Step Amphetamine Test Strip and Device cleared by the FDA?
Acon Amp 300 One Step Amphetamine Test Strip and Device (K041822) received a 510(k) decision of Substantially Equivalent on September 16, 2004, 72 days after the submission was received.
What is the product code of K041822?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.