The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Amylase Cnpg3.
Device ID | K931141 |
510k Number | K931141 |
Device Name: | BIOTROL AMYLASE CNPG3 |
Classification | Saccharogenic, Amylase |
Applicant | BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
Contact | Allan C Murphy |
Correspondent | Allan C Murphy BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
Product Code | CIJ |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-05 |
Decision Date | 1993-05-26 |