FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDITECH IMMUTEST MILTI-DRUG SCREEN
K Number: K113046
·
Decision Nov 10, 2011
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
14
Review Days
28
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Basic Information
- Device Name
- AMEDITECH IMMUTEST MILTI-DRUG SCREEN
- K Number
- K113046
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ameditech, Inc.
- Date Received
- October 13, 2011
- Decision Date
- November 10, 2011
- Product Code
- DKZ
- 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 |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Ameditech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | Dec 5, 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 |
| K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES | Nov 30, 2001 | Substantially Equivalent |
| K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE | Nov 30, 2001 | Substantially Equivalent |
| K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP | Nov 30, 2001 | Substantially Equivalent |