The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlite Processing Center.
Device ID | K915680 |
510k Number | K915680 |
Device Name: | AMERLITE PROCESSING CENTER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Yvonne Adair |
Correspondent | Yvonne Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-19 |
Decision Date | 1992-03-11 |