The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hichem Calcium Reagent Kit.
| Device ID | K981794 |
| 510k Number | K981794 |
| Device Name: | HICHEM CALCIUM REAGENT KIT |
| Classification | Azo Dye, Calcium |
| Applicant | HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92621 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-07-29 |
| Summary: | summary |