The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Cholesterol (total) Analysis Products.
| Device ID | K870928 |
| 510k Number | K870928 |
| Device Name: | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Labrec, Phd |
| Correspondent | Labrec, Phd ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-09 |
| Decision Date | 1987-04-22 |