The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektachem Clinical Chemistry Slides (ck-mb).
Device ID | K861387 |
510k Number | K861387 |
Device Name: | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) |
Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Contact | Philip J Harter |
Correspondent | Philip J Harter EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
Product Code | JHS |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-14 |
Decision Date | 1986-06-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750005154 | K861387 | 000 |
10758750005123 | K861387 | 000 |