The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Direct-amylase Test Reagent.
| Device ID | K011843 |
| 510k Number | K011843 |
| Device Name: | GENZYME DIRECT-AMYLASE TEST REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562 |
| Contact | Barbara Pizza |
| Correspondent | Barbara Pizza GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-08-10 |
| Summary: | summary |