FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K Number: K090844
·
Decision Jul 30, 2009
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
50
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
- K Number
- K090844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lin-Zhi International, Inc.
- Date Received
- March 27, 2009
- Decision Date
- July 30, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJG), ordered by most recent decision date.
Labcorp Fentanyl Urine Visual Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Evidence MultiSTAT DOA Urine MultiPlex
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Buprenorphine II Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEFRIA Hydrocodone Oral Fluid
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Fentanyl III Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Lin-Zhi International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Jan 16, 2026 | Substantially Equivalent |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Jun 18, 2025 | Substantially Equivalent |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | Sep 17, 2020 | Substantially Equivalent |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Aug 7, 2020 | Substantially Equivalent |
| K201223 | LZI Tramadol Enzyme Immunoassay | Jun 4, 2020 | Substantially Equivalent |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Nov 21, 2019 | Substantially Equivalent |
| K192433 | LZI Methadone II Enzyme Immunoassay | Oct 4, 2019 | Substantially Equivalent |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Dec 3, 2018 | Substantially Equivalent |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Apr 20, 2018 | Unknown |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Jun 26, 2017 | Substantially Equivalent |