510(k) K850254

PARATHYROID HORMONE RADIOIMMUNOASSAY KIT by Cambridge Medical Technology — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type