510(k) K850254

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

K850254 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "PARATHYROID HORMONE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 3, 1985. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

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