510(k) K023626
K023626 is an FDA 510(k) premarket notification submitted by Quest Diagnostics, Inc. for the device "AML HAIRCHECK-DT (COCAINE)". The FDA issued a decision of Substantially Equivalent on September 29, 2003. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Quest Diagnostics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2003
- Date Received
- October 29, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type