The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hichem Ise Standards Kit 70011.
| Device ID | K953863 |
| 510k Number | K953863 |
| Device Name: | HICHEM ISE STANDARDS KIT 70011 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1995-09-06 |