The following data is part of a premarket notification filed by Industrial Chemical Measurement with the FDA for Discrete Photometric Chemistry Analyser.
Device ID | K904783 |
510k Number | K904783 |
Device Name: | DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | INDUSTRIAL CHEMICAL MEASUREMENT BOX 1079 Hillsboro, OR 97123 |
Contact | Frank Thomas |
Correspondent | Frank Thomas INDUSTRIAL CHEMICAL MEASUREMENT BOX 1079 Hillsboro, OR 97123 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-22 |
Decision Date | 1991-04-18 |