510(k) K841042

MATCHED COMPONENT SET RADIOIMMUNOASSAY by Cambridge Medical Technology — Product Code CDZ

K841042 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "MATCHED COMPONENT SET RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on April 19, 1984. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type