Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device
FDA 510(k) K040274 · ACON Laboratories, Inc.
510(k) numberK040274
Submission
- Device name
- Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- February 5, 2004
- Decision date
- May 3, 2004
- 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 Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device cleared by the FDA?
Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device (K040274) received a 510(k) decision of Substantially Equivalent on May 3, 2004, 88 days after the submission was received.
What is the product code of K040274?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.