The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for 17-alpha-hydroxyprogesterone (17-oh-p) Neo. Ria.
| Device ID | K885198 |
| 510k Number | K885198 |
| Device Name: | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Contact | Robert Hudak |
| Correspondent | Robert Hudak ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-16 |
| Decision Date | 1989-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830023150 | K885198 | 000 |