The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Ethanol Controls, Urine, Levels 1,ii, And Iii.
Device ID | K932067 |
510k Number | K932067 |
Device Name: | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III |
Classification | Alcohol Control Materials |
Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
Contact | Leo Bressler |
Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
Product Code | DKC |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-29 |
Decision Date | 1993-06-16 |