The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Total Protein.
Device ID | K854553 |
510k Number | K854553 |
Device Name: | TOTAL PROTEIN |
Classification | Biuret (colorimetric), Total Protein |
Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Contact | Linda M Chinn |
Correspondent | Linda M Chinn AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Product Code | CEK |
CFR Regulation Number | 862.1635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-13 |
Decision Date | 1985-11-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOTAL PROTEIN 85826834 4515897 Live/Registered |
Jay Cutler Elite, LLC 2013-01-18 |