The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Accu-zyme Ii Enzymatic Reagent.
| Device ID | K791640 |
| 510k Number | K791640 |
| Device Name: | COULTER ACCU-ZYME II ENZYMATIC REAGENT |
| 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 | 1979-08-21 |
| Decision Date | 1979-09-24 |