The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Emds Albumin (alb) Test.
| Device ID | K935179 |
| 510k Number | K935179 |
| Device Name: | EMDS ALBUMIN (ALB) TEST |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1993-12-17 |