The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Spinal Fluid Control.
| Device ID | K851820 |
| 510k Number | K851820 |
| Device Name: | SPINAL FLUID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Ernest S Johnson |
| Correspondent | Ernest S Johnson IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-07-15 |