510(k) K841478
K841478 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIANEN CYCLIC-AMP RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 14, 1984. The device falls under product code CHO (Radioimmunoassay, Cyclic Amp), a Class II device regulated under 21 CFR 862.1230. New England Nuclear has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1984
- Date Received
- April 9, 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