510(k) K021688
K021688 is an FDA 510(k) premarket notification submitted by Nymox Pharmaceutical Corporation for the device "NICALERT". The FDA issued a decision of Substantially Equivalent on October 18, 2002. The device falls under product code MRS (Test System, Nicotine, Cotinine, Metabolites), a Class I device regulated under 21 CFR 862.3220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2002
- Date Received
- May 22, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test System, Nicotine, Cotinine, Metabolites
- Device Class
- Class I
- Regulation Number
- 862.3220
- Review Panel
- TX
- Submission Type