510(k) K844135
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