The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innofluor Phenytoin Assay System.
| Device ID | K955562 |
| 510k Number | K955562 |
| Device Name: | INNOFLUOR PHENYTOIN ASSAY SYSTEM |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
| Contact | Lynda M Taylor |
| Correspondent | Lynda M Taylor OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-06 |
| Decision Date | 1996-01-24 |