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 |