The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Progesterone System By Eia.
Device ID | K864156 |
510k Number | K864156 |
Device Name: | PROGESTERONE SYSTEM BY EIA |
Classification | Radioimmunoassay, Progesterone |
Applicant | INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland, OR 97202 |
Contact | Buck, Phd |
Correspondent | Buck, Phd INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland, OR 97202 |
Product Code | JLS |
CFR Regulation Number | 862.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-23 |
Decision Date | 1986-11-24 |