The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Human Serum Electrolyte Control-liquid.
| Device ID | K834505 |
| 510k Number | K834505 |
| Device Name: | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | QUANTIMETRIX CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-04-13 |