The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Smac (sequential Mult. Analysis Comp..
| Device ID | K792138 |
| 510k Number | K792138 |
| Device Name: | SMAC (SEQUENTIAL MULT. ANALYSIS COMP. |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-22 |
| Decision Date | 1979-11-13 |