The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Ammonia/ethanol Controls, High/low, Cat.# A7937/7812.
| Device ID | K933425 |
| 510k Number | K933425 |
| Device Name: | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 |
| 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 | 1993-07-13 |
| Decision Date | 1993-11-16 |