510(k) K812986
K812986 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "AGGLUTEX AMPHETAMINE TEST KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code DJP (Radioimmunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1982
- Date Received
- October 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Amphetamine
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type