The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Immuchem Neonatal Tsh-mp Elisa.
| Device ID | K913963 |
| 510k Number | K913963 |
| Device Name: | IMMUCHEM NEONATAL TSH-MP ELISA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Contact | Jeffrey C Travis |
| Correspondent | Jeffrey C Travis ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022412 | K913963 | 000 |
| 00817830022405 | K913963 | 000 |