The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Aqueous Multianalyte Line Stand, Modified.
| Device ID | K911803 |
| 510k Number | K911803 |
| Device Name: | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-23 |
| Decision Date | 1991-05-15 |