510(k) K982211
K982211 is an FDA 510(k) premarket notification submitted by Medtox Diagnostics, Inc. for the device "PROFILE-II MODEL 600582". The FDA issued a decision of Substantially Equivalent on July 29, 1998. The device falls under product code DKE (Reagents, Test, Tetrahydrocannabinol), a Class II device regulated under 21 CFR 862.3870. Medtox Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1998
- Date Received
- June 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagents, Test, Tetrahydrocannabinol
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type