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 |