FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
K Number: K041747
·
Decision Nov 24, 2004
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
3
Review Days
148
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
- IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
- K Number
- K041747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lifepoint,Inc
- Date Received
- June 29, 2004
- Decision Date
- November 24, 2004
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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