The following data is part of a premarket notification filed by Damon Corp. with the FDA for Liquisol Progesterone Radioimmuno.
Device ID | K820686 |
510k Number | K820686 |
Device Name: | LIQUISOL PROGESTERONE RADIOIMMUNO |
Classification | Radioimmunoassay, Progesterone |
Applicant | DAMON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JLS |
CFR Regulation Number | 862.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-11 |
Decision Date | 1982-04-01 |