510(k) K963733
K963733 is an FDA 510(k) premarket notification submitted by Dynagen, Inc. for the device "NICCHECK I". The FDA issued a decision of Substantially Equivalent on December 13, 1996. The device falls under product code MRS (Test System, Nicotine, Cotinine, Metabolites), a Class I device regulated under 21 CFR 862.3220. Dynagen, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1996
- Date Received
- September 16, 1996
- 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