FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE ACETAMINOPHEN
K Number: K013757
·
Decision Jan 8, 2002
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
264
Review Days
56
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Basic Information
- Device Name
- ROCHE ACETAMINOPHEN
- K Number
- K013757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 13, 2001
- Decision Date
- January 8, 2002
- 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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