FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKTOX MULTIPLE DRUG DIPCARD
K Number: K023489
·
Decision Dec 16, 2002
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
144
Applicant Total
13
Review Days
60
Basic Information
- Device Name
- QUICKTOX MULTIPLE DRUG DIPCARD
- K Number
- K023489
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BRANAN MEDICAL CORP.
- Date Received
- October 17, 2002
- Decision Date
- December 16, 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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