The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Sodium/potassium Serum Range Linearity Standards.
| Device ID | K881436 |
| 510k Number | K881436 |
| Device Name: | SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-05 |
| Decision Date | 1988-06-02 |