The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Dt Slides (urcr).
Device ID | K934071 |
510k Number | K934071 |
Device Name: | KODAK EKTACHEM DT SLIDES (URCR) |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Contact | Bradford M Spring |
Correspondent | Bradford M Spring EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
Product Code | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-20 |
Decision Date | 1994-03-21 |