The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Low/mid/high Aqueous Glucose Control.
| Device ID | K913792 |
| 510k Number | K913792 |
| Device Name: | HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Bentley Tam |
| Correspondent | Bentley Tam HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1991-09-25 |