FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIAGE TOX DRUG SCREEN
K Number: K043242
·
Decision Feb 28, 2005
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
46
Review Days
97
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Basic Information
- Device Name
- TRIAGE TOX DRUG SCREEN
- K Number
- K043242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosite Incorporated
- Date Received
- November 23, 2004
- Decision Date
- February 28, 2005
- Product Code
- LDP
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDP), ordered by most recent decision date.
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ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
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DIMENSION VISTA FLEX REAGENT CARTRIDGES
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Other Clearances by Biosite Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Jun 11, 2010 | Substantially Equivalent |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Apr 19, 2010 | Substantially Equivalent |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | Nov 13, 2009 | Substantially Equivalent |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Jun 6, 2008 | Substantially Equivalent |
| 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 |