The following data is part of a premarket notification filed by Enzyme Technology, Inc. with the FDA for Cholesterol, Universal Et.
| Device ID | K896073 |
| 510k Number | K896073 |
| Device Name: | CHOLESTEROL, UNIVERSAL ET |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ENZYME TECHNOLOGY, INC. 427-3 AMHERST ST., SUITE 132 Nashua, NH 03063 |
| Contact | Peter R Klamka |
| Correspondent | Peter R Klamka ENZYME TECHNOLOGY, INC. 427-3 AMHERST ST., SUITE 132 Nashua, NH 03063 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1989-12-12 |