The following data is part of a premarket notification filed by Biocell Laboratories, Inc. with the FDA for Biocell Spinal Fluid Control.
| Device ID | K830179 |
| 510k Number | K830179 |
| Device Name: | BIOCELL SPINAL FLUID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOCELL LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-18 |