The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Gamma Smac Reagents.
| Device ID | K790578 |
| 510k Number | K790578 |
| Device Name: | GAMMA SMAC REAGENTS |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-27 |
| Decision Date | 1979-05-15 |