510(k) K992990
K992990 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUICKPAC II ONE STEP COCAINE TEST". The FDA issued a decision of Substantially Equivalent on September 20, 1999. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1999
- Date Received
- September 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type