The following data is part of a premarket notification filed by Pandex Laboratories, Inc. with the FDA for Fluorescence Concentration Analyzer (fca).
Device ID | K864699 |
510k Number | K864699 |
Device Name: | FLUORESCENCE CONCENTRATION ANALYZER (FCA) |
Classification | Fluorometer |
Applicant | PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein, IL 60060 |
Contact | Hank Juske |
Correspondent | Hank Juske PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein, IL 60060 |
Product Code | JZT |
CFR Regulation Number | 866.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-02 |
Decision Date | 1986-12-22 |