The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Excel (tm) Chemistry Analyzer.
Device ID | K893137 |
510k Number | K893137 |
Device Name: | EXCEL (TM) CHEMISTRY ANALYZER |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Contact | Jennifer Line |
Correspondent | Jennifer Line AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-25 |
Decision Date | 1989-08-10 |