The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Procedure No. 333-uv.
| Device ID | K914777 |
| 510k Number | K914777 |
| Device Name: | SIGMA PROCEDURE NO. 333-UV |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1991-12-27 |