The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme A-amylase Test Reagent.
| Device ID | K933397 |
| 510k Number | K933397 |
| Device Name: | GENZYME A-AMYLASE TEST REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Alodia Ruiz |
| Correspondent | Alodia Ruiz 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 | 1993-07-12 |
| Decision Date | 1993-10-28 |