The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Prolactin 125i Kit.
Device ID | K831345 |
510k Number | K831345 |
Device Name: | RIANEN PROLACTIN 125I KIT |
Classification | Radioimmunoassay, Prolactin (lactogen) |
Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFT |
CFR Regulation Number | 862.1625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-25 |
Decision Date | 1983-06-08 |