The following data is part of a premarket notification filed by Verichem Laboratories, Inc. with the FDA for Electrolyte Control.
| Device ID | K912513 |
| 510k Number | K912513 |
| Device Name: | ELECTROLYTE CONTROL |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Contact | Anthony J Dimonte |
| Correspondent | Anthony J Dimonte VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. Providence, RI 02907 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-06 |
| Decision Date | 1991-07-19 |