The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Enzymatic Reagent For Cholesterol Meas.
| Device ID | K781013 |
| 510k Number | K781013 |
| Device Name: | ENZYMATIC REAGENT FOR CHOLESTEROL MEAS |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-16 |
| Decision Date | 1978-07-28 |