The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Amylase Reagent.
Device ID | K921057 |
510k Number | K921057 |
Device Name: | AMYLASE REAGENT |
Classification | Catalytic Methods, Amylase |
Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
Contact | Russell H Herndon |
Correspondent | Russell H Herndon GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
Product Code | JFJ |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-05 |
Decision Date | 1992-03-27 |