FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEDIA DAU COCAINE ASSAY
K Number: K945345
·
Decision Jan 17, 1995
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
107
Review Days
77
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Basic Information
- Device Name
- CEDIA DAU COCAINE ASSAY
- K Number
- K945345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- November 1, 1994
- Decision Date
- January 17, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
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Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
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DRI Cocaine Metabolite Assay
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Emit II Plus Cocaine Metabolite Assay
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Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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