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 |