FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synermed Opiate Enzyme Immunoassay
K Number: K172416
·
Decision Apr 19, 2018
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
3
Review Days
252
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Basic Information
- Device Name
- Synermed Opiate Enzyme Immunoassay
- K Number
- K172416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infrared Laboratory Systems, LLC (Dba Synermed)
- Date Received
- August 10, 2017
- Decision Date
- April 19, 2018
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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