510(k) K141647
K141647 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)". The FDA issued a decision of Substantially Equivalent on July 17, 2014. The device falls under product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), a Class II device regulated under 21 CFR 862.3250. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2014
- Date Received
- June 19, 2014
- 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