The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Modified Hi Chem Amylase Reagent (product #88129).
| Device ID | K895555 |
| 510k Number | K895555 |
| Device Name: | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) |
| Classification | Amyloclastic, Amylase |
| 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 | CJA |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-12-22 |