FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NICALERT
K Number: K021688
·
Decision Oct 18, 2002
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
2
Applicant Total
1
Review Days
149
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Basic Information
- Device Name
- NICALERT
- K Number
- K021688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nymox Pharmaceutical Corporation
- Date Received
- May 22, 2002
- Decision Date
- October 18, 2002
- Product Code
- MRS
- 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 |
|---|---|---|---|
| MRS | Test System, Nicotine, Cotinine, Metabolites | FDA class 1 | Clinical Toxicology |
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