The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Analyst Analytical Test Rotor:chem-14,cali.
Device ID | K901017 |
510k Number | K901017 |
Device Name: | DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI |
Classification | Catalytic Methods, Amylase |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Contact | Richard M Vaught |
Correspondent | Richard M Vaught E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Product Code | JFJ |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-05 |
Decision Date | 1990-05-15 |