The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Trak Liquid Cerebrospinal Fluid Control Levels 1 & 2.
| Device ID | K941328 |
| 510k Number | K941328 |
| Device Name: | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Patricia V Willis |
| Correspondent | Patricia V Willis MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-08-18 |