The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Enzyme Linearity Standards (prod. 88235).
| Device ID | K902321 |
| 510k Number | K902321 |
| Device Name: | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Ralph Bolstad |
| Correspondent | Ralph Bolstad HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-23 |
| Decision Date | 1990-06-28 |