The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (phos).
Device ID | K932729 |
510k Number | K932729 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Bradford M Spring |
Correspondent | Bradford M Spring EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-07 |
Decision Date | 1993-08-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750009220 | K932729 | 000 |