The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Amylase Method/dimension(r) Clinical Chemistry Sys.
| Device ID | K930489 |
| 510k Number | K930489 |
| Device Name: | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-29 |
| Decision Date | 1993-05-12 |