The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Ise Reagents (products #88960 And #88964).
| Device ID | K902155 |
| 510k Number | K902155 |
| Device Name: | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) |
| Classification | Method, Metallic Reduction, Glucose (urinary, Non-quantitative) |
| 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 | JIM |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-06-12 |