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 |