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 |