The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Assay System, 125i Kit.
Device ID | K781495 |
510k Number | K781495 |
Device Name: | RIANEN ASSAY SYSTEM, 125I KIT |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DNL |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-30 |
Decision Date | 1978-09-14 |