The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Direct Bilirubin Test Technicon Ra 1000.
| Device ID | K922856 |
| 510k Number | K922856 |
| Device Name: | SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1992-09-09 |