The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Alt -lts.
Device ID | K832639 |
510k Number | K832639 |
Device Name: | ALT -LTS |
Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CKA |
CFR Regulation Number | 862.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-04 |
Decision Date | 1983-09-12 |