The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Valproic Acid Fpia Reagent Set And Calibrators.
Device ID | K943866 |
510k Number | K943866 |
Device Name: | VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS |
Classification | Enzyme Immunoassay, Valproic Acid |
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 | LEG |
CFR Regulation Number | 862.3645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-08 |
Decision Date | 1994-11-10 |