The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Cerebrospinal Fluid Protein Testpack, #67668/95.
| Device ID | K863478 |
| 510k Number | K863478 |
| Device Name: | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 |
| Classification | Turbidimetric, Total Protein |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 |
| Contact | RAYMOND L MILLER |
| Correspondent | RAYMOND L MILLER 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 | 1986-09-09 |
| Decision Date | 1986-10-29 |