FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
K Number: K141406
·
Decision Jul 1, 2014
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
50
Review Days
34
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Basic Information
- Device Name
- IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
- K Number
- K141406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunalysis Corporation
- Date Received
- May 28, 2014
- Decision Date
- July 1, 2014
- 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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| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Nov 15, 2019 | Substantially Equivalent |
| K183048 | Quantisal II Oral Fluid Collection Device | Jul 29, 2019 | Substantially Equivalent |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Jan 24, 2019 | Substantially Equivalent |