Acon Tri-Fect Drug Screen Test Device
FDA 510(k) K041743 · ACON Laboratories, Inc.
510(k) numberK041743
Submission
- Device name
- Acon Tri-Fect Drug Screen Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- June 28, 2004
- Decision date
- September 9, 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 Tri-Fect Drug Screen Test Device cleared by the FDA?
Acon Tri-Fect Drug Screen Test Device (K041743) received a 510(k) decision of Substantially Equivalent on September 9, 2004, 73 days after the submission was received.
What is the product code of K041743?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.