510(k) K792588
K792588 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TERRITIN RIA KIT". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1980
- Date Received
- December 17, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- CH
- Submission Type