The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Cyclic Adenosine Monophoshate By Radio.
Device ID | K823504 |
510k Number | K823504 |
Device Name: | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO |
Classification | Radioimmunoassay, Cyclic Amp |
Applicant | IMMUNO NUCLEAR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHO |
CFR Regulation Number | 862.1230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-24 |
Decision Date | 1983-01-28 |