The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immophase Insulin (125i) Radioassay.
Device ID | K811953 |
510k Number | K811953 |
Device Name: | IMMOPHASE INSULIN (125I) RADIOASSAY |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1981-07-08 |
Decision Date | 1981-07-23 |