The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slide Alcohol (alc).
Device ID | K934273 |
510k Number | K934273 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) |
Classification | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
Applicant | EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester, NY 14652 -0882 |
Contact | Yvonne E Middlefell |
Correspondent | Yvonne E Middlefell EASTMAN KODAK COMPANY 100 INDIGO CREEK DR. Rochester, NY 14652 -0882 |
Product Code | DMT |
CFR Regulation Number | 862.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-31 |
Decision Date | 1994-03-21 |