The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Range-chek.
| Device ID | K854789 |
| 510k Number | K854789 |
| Device Name: | RANGE-CHEK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-29 |
| Decision Date | 1986-01-13 |