The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Reagent, Trigly. C-zyme Ndc#12739-0017-1.
| Device ID | K760195 |
| 510k Number | K760195 |
| Device Name: | REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-06 |
| Decision Date | 1976-08-03 |