The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ion 2 Reagent Ki.
| Device ID | K851350 |
| 510k Number | K851350 |
| Device Name: | ION 2 REAGENT KI |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea, CA 92621 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-04-29 |