The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Plasma Cyclic Adenosine Monophosphate By Radioimmu.
| Device ID | K844135 |
| 510k Number | K844135 |
| Device Name: | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU |
| Classification | Radioimmunoassay, Cyclic Amp |
| Applicant | IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater, MN 55082 |
| Contact | Lisa J Andersen |
| Correspondent | Lisa J Andersen IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater, MN 55082 |
| Product Code | CHO |
| CFR Regulation Number | 862.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-03-05 |