The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Rsl Insulin Kit.
Device ID | K772281 |
510k Number | K772281 |
Device Name: | RSL INSULIN KIT |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 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 | 1977-12-12 |
Decision Date | 1978-01-06 |