510(k) K820391
K820391 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1982
- Date Received
- February 10, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Cannabinoid(S)
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type