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 |