The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Phenytoin Fpia Reagent Set And Calibrators.
| Device ID | K943313 |
| 510k Number | K943313 |
| Device Name: | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Hoyle D Hill |
| Correspondent | Hoyle D Hill SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-11 |
| Decision Date | 1994-10-27 |