The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Direct Bilirubin Cat. No. 65406.
| Device ID | K932159 |
| 510k Number | K932159 |
| Device Name: | SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 |
| 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 | 1993-05-04 |
| Decision Date | 1993-09-21 |