FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K Number: K092048
·
Decision Apr 19, 2010
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
62
Applicant Total
46
Review Days
286
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Basic Information
- Device Name
- ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
- K Number
- K092048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3620
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosite Incorporated
- Date Received
- July 7, 2009
- Decision Date
- April 19, 2010
- Product Code
- DJR
- 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 |
|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | FDA class 2 | Clinical Toxicology |
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Other Clearances by Biosite Incorporated
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|---|---|---|---|
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| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | Dec 7, 2007 | Substantially Equivalent |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | Mar 1, 2007 | Substantially Equivalent |
| K062530 | TRIAGE PROTEIN C TEST | Jan 29, 2007 | Substantially Equivalent |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Jul 10, 2006 | Substantially Equivalent |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Jun 22, 2006 | Substantially Equivalent |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Jan 23, 2006 | Substantially Equivalent |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | Sep 22, 2005 | Substantially Equivalent |