The following data is part of a premarket notification filed by New England Nuclear with the FDA for Kit, Ria, Gentamicin Sulf..
Device ID | K760068 |
510k Number | K760068 |
Device Name: | KIT, RIA, GENTAMICIN SULF. |
Classification | Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DJB |
CFR Regulation Number | 862.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-16 |
Decision Date | 1976-07-20 |