The following data is part of a premarket notification filed by Environmental Sciences Assoc., Inc. with the FDA for Model 5100 Electrochemical Detector.
Device ID | K801439 |
510k Number | K801439 |
Device Name: | MODEL 5100 ELECTROCHEMICAL DETECTOR |
Classification | Detectors, Electrochemical, Liquid Chromatography |
Applicant | ENVIRONMENTAL SCIENCES ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LEQ |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-20 |
Decision Date | 1980-07-21 |