The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Psi Amylase Reagent.
| Device ID | K864464 |
| 510k Number | K864464 |
| Device Name: | PSI AMYLASE REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-12 |
| Decision Date | 1987-01-21 |