The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Cyclic-amp Radioimmunoassay.
Device ID | K841478 |
510k Number | K841478 |
Device Name: | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY |
Classification | Radioimmunoassay, Cyclic Amp |
Applicant | NEW ENGLAND NUCLEAR 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 | 1984-04-09 |
Decision Date | 1984-06-14 |