The following data is part of a premarket notification filed by Western Laboratories Corp. with the FDA for Model 100 Bicarbonate Conductivity.
| Device ID | K821834 |
| 510k Number | K821834 |
| Device Name: | MODEL 100 BICARBONATE CONDUCTIVITY |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | WESTERN LABORATORIES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-22 |
| Decision Date | 1982-07-02 |