The following data is part of a premarket notification filed by Inter Science Institute with the FDA for Glucagon Ria Module.
Device ID | K771948 |
510k Number | K771948 |
Device Name: | GLUCAGON RIA MODULE |
Classification | Radioimmunoassay, Glucagon |
Applicant | INTER SCIENCE INSTITUTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JME |
CFR Regulation Number | 862.1335 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-17 |
Decision Date | 1978-01-20 |