FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K Number: K012483
·
Decision Nov 30, 2001
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
14
Review Days
120
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
- AMEDITECH IMMUTEST DRUG SCREEN OPIATES
- K Number
- K012483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameditech, Inc.
- Date Received
- August 2, 2001
- Decision Date
- November 30, 2001
- 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 Ameditech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | Dec 5, 2011 | Substantially Equivalent |
| K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN | Nov 10, 2011 | Substantially Equivalent |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 | Dec 20, 2006 | Substantially Equivalent |
| K053175 | AMEDITECH DRUGSMARTCUP | Dec 8, 2005 | Substantially Equivalent |
| K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III | Mar 4, 2005 | Substantially Equivalent |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | Dec 29, 2004 | Substantially Equivalent |
| K040092 | AMEDITECH IMMU TEST DRUG SCREEN PANEL | Mar 8, 2004 | Substantially Equivalent |
| K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST | Nov 18, 2002 | Substantially Equivalent |
| K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE | Nov 30, 2001 | Substantially Equivalent |
| K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP | Nov 30, 2001 | Substantially Equivalent |