510(k) K782125
K782125 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "RIA KIT, KANAMYCIN". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code KJI (Radioimmunoassay, Kanamycin), a Class II device regulated under 21 CFR 862.3520. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1979
- Date Received
- December 27, 1978
- 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