510(k) K792588

TERRITIN RIA KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JMG

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