The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Phenytoin Kit Fluorescence Polarization.
| Device ID | K842586 |
| 510k Number | K842586 |
| Device Name: | PHENYTOIN KIT FLUORESCENCE POLARIZATION |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | WINDSOR LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-03 |
| Decision Date | 1984-09-26 |