The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate(tm) Direct Bilirubin Catalog No. 65406.
| Device ID | K902123 |
| 510k Number | K902123 |
| Device Name: | SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | G Bentley |
| Correspondent | G Bentley 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 | 1990-05-11 |
| Decision Date | 1990-06-06 |