FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
K Number: K150606
·
Decision Oct 23, 2015
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
209
Applicant Total
32
Review Days
227
Basic Information
- Device Name
- Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
- K Number
- K150606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Date Received
- March 10, 2015
- Decision Date
- October 23, 2015
- 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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