Emit II Plus Oxycodone Assay
FDA 510(k) K172910 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK172910
Submission
- Device name
- Emit II Plus Oxycodone Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- September 25, 2017
- Decision date
- October 18, 2017
- 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 Emit II Plus Oxycodone Assay cleared by the FDA?
Emit II Plus Oxycodone Assay (K172910) received a 510(k) decision of Substantially Equivalent on October 18, 2017, 23 days after the submission was received.
What is the product code of K172910?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.