510(k) K823504

CYCLIC ADENOSINE MONOPHOSHATE BY RADIO by Immuno Nuclear Corp. — Product Code CHO

K823504 is an FDA 510(k) premarket notification submitted by Immuno Nuclear Corp. for the device "CYCLIC ADENOSINE MONOPHOSHATE BY RADIO". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code CHO (Radioimmunoassay, Cyclic Amp), a Class II device regulated under 21 CFR 862.1230. Immuno Nuclear Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
November 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cyclic Amp
Device Class
Class II
Regulation Number
862.1230
Review Panel
CH
Submission Type