510(k) K822808
K822808 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX KENAMYCIN". The FDA issued a decision of Substantially Equivalent on October 8, 1982. The device falls under product code KJI (Radioimmunoassay, Kanamycin), a Class II device regulated under 21 CFR 862.3520. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1982
- Date Received
- September 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Kanamycin
- Device Class
- Class II
- Regulation Number
- 862.3520
- Review Panel
- TX
- Submission Type