The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Emds(tm) Cerebrospinal Fluid Protein, #67668/95.
| Device ID | K901083 |
| 510k Number | K901083 |
| Device Name: | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 |
| Classification | Turbidimetric, Total Protein |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-07 |
| Decision Date | 1990-04-16 |