The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Immuchem Phe-mw Ea.
| Device ID | K926106 |
| 510k Number | K926106 |
| Device Name: | IMMUCHEM PHE-MW EA |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| 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 | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1995-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022351 | K926106 | 000 |
| 00817830022344 | K926106 | 000 |
| 00817830022337 | K926106 | 000 |
| 00817830022320 | K926106 | 000 |