The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Aqueous Glucose Control, Low, Med, High.
| Device ID | K941433 |
| 510k Number | K941433 |
| Device Name: | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-08-02 |