The following data is part of a premarket notification filed by Stat Engineering with the FDA for Perkin Elmer Model 91 Amylase Reagent.
| Device ID | K801096 |
| 510k Number | K801096 |
| Device Name: | PERKIN ELMER MODEL 91 AMYLASE REAGENT |
| Classification | Nephelometric, Amylase |
| Applicant | STAT ENGINEERING 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 | 1980-05-09 |
| Decision Date | 1980-06-09 |