Acon Oxy II One Step Oxycodone Test Strip; Test Device
FDA 510(k) K043507 · ACON Laboratories, Inc.
510(k) numberK043507
Submission
- Device name
- Acon Oxy II One Step Oxycodone Test Strip; Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- December 20, 2004
- Decision date
- February 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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Questions and answers
When was Acon Oxy II One Step Oxycodone Test Strip; Test Device cleared by the FDA?
Acon Oxy II One Step Oxycodone Test Strip; Test Device (K043507) received a 510(k) decision of Substantially Equivalent on February 25, 2005, 67 days after the submission was received.
What is the product code of K043507?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.