The following data is part of a premarket notification filed by Icn Pharmaceuticals, Inc. with the FDA for Immuchem Gal-mw Ea.
| Device ID | K951329 |
| 510k Number | K951329 |
| Device Name: | IMMUCHEM GAL-MW EA |
| Classification | Enzymatic Methods, Galactose |
| Applicant | ICN PHARMACEUTICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen ICN PHARMACEUTICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Product Code | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239014894 | K951329 | 000 |
| 00840239014887 | K951329 | 000 |
| 00840239014870 | K951329 | 000 |
| 00840239014863 | K951329 | 000 |
| 00817830023129 | K951329 | 000 |
| 00817830023112 | K951329 | 000 |
| 00817830023105 | K951329 | 000 |
| 00817830023099 | K951329 | 000 |