The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Amylase Reagent #88129.
| Device ID | K831295 |
| 510k Number | K831295 |
| Device Name: | AMYLASE REAGENT #88129 |
| Classification | Nephelometric, Amylase |
| Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHM |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-20 |
| Decision Date | 1983-06-30 |