The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Calibrator A+.
| Device ID | K895135 |
| 510k Number | K895135 |
| Device Name: | HI CHEM CALIBRATOR A+ |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-16 |
| Decision Date | 1989-10-23 |