The following data is part of a premarket notification filed by Gilford Instrument Laboratories, Inc. with the FDA for Thermo Set Electronic Tem. Controller.
Device ID | K780888 |
510k Number | K780888 |
Device Name: | THERMO SET ELECTRONIC TEM. CONTROLLER |
Classification | Cuvette, Thermostated |
Applicant | GILFORD INSTRUMENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JRI |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-26 |
Decision Date | 1978-06-28 |