The following data is part of a premarket notification filed by Endocrine-metabolic Center with the FDA for Ria, Insulin, Double Antibody.
Device ID | K790630 |
510k Number | K790630 |
Device Name: | RIA, INSULIN, DOUBLE ANTIBODY |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | ENDOCRINE-METABOLIC CENTER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFP |
CFR Regulation Number | 862.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-27 |
Decision Date | 1979-07-24 |