510(k) K981585
K981585 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)". The FDA issued a decision of Substantially Equivalent on May 28, 1998. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1998
- Date Received
- May 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cannabinoids
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type