Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device
FDA 510(k) K060466 · ACON Laboratories, Inc.
510(k) numberK060466
Submission
- Device name
- Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- February 22, 2006
- Decision date
- April 21, 2006
- 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 Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device cleared by the FDA?
Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device (K060466) received a 510(k) decision of Substantially Equivalent on April 21, 2006, 58 days after the submission was received.
What is the product code of K060466?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.