510(k) K844135

PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU by Immuno Nuclear Corp. — Product Code CHO

K844135 is an FDA 510(k) premarket notification submitted by Immuno Nuclear Corp. for the device "PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU". The FDA issued a decision of Substantially Equivalent on March 5, 1985. 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
March 5, 1985
Date Received
October 23, 1984
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