510(k) K924113
K924113 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN ONLINE FOR COCAINE METABOLITE". The FDA issued a decision of Substantially Equivalent on Dec 28, 1992. The device falls under product code DLN (Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)), a Class II device regulated under 21 CFR 862.3250. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 1992
- Date Received
- Aug 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type