510(k) K811927

1F BLOCKING ANTIBODY(57 CO) RADIOASSAY by Corning Medical & Scientific — Product Code LIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1982
Date Received
July 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type