The following data is part of a premarket notification filed by Immuno-diagnostic Laboratories with the FDA for Angiotensin Converting Enzyme.
Device ID | K833777 |
510k Number | K833777 |
Device Name: | ANGIOTENSIN CONVERTING ENZYME |
Classification | Radioimmunoassay, Angiotensin I And Renin |
Applicant | IMMUNO-DIAGNOSTIC LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIB |
CFR Regulation Number | 862.1085 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-27 |
Decision Date | 1984-01-30 |