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 |