The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Direct Amylase Verifier.
| Device ID | K993132 |
| 510k Number | K993132 |
| Device Name: | GENZYME DIRECT AMYLASE VERIFIER |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-10-04 |
| Summary: | summary |