The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Eni Blood Urea Nitrogen Reagent.
Device ID | K844065 |
510k Number | K844065 |
Device Name: | ENI BLOOD UREA NITROGEN REAGENT |
Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Contact | Eugene H Labrec |
Correspondent | Eugene H Labrec ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Product Code | CDQ |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-18 |
Decision Date | 1984-11-27 |