FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS INTEGRA ONLINE DAT II COCAINE II
K Number: K023296
·
Decision Nov 25, 2002
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
264
Review Days
54
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Basic Information
- Device Name
- COBAS INTEGRA ONLINE DAT II COCAINE II
- K Number
- K023296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- October 2, 2002
- Decision Date
- November 25, 2002
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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