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 |