The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem 700 Analyzer.
Device ID | K833833 |
510k Number | K833833 |
Device Name: | KODAK EKTACHEM 700 ANALYZER |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | EASTMAN KODAK COMPANY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-03 |
Decision Date | 1984-01-17 |