The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Dimension Psid Clinical Chemistry System.
Device ID | K893775 |
510k Number | K893775 |
Device Name: | DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Richard M Vaught |
Correspondent | Richard M Vaught E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-22 |
Decision Date | 1989-07-25 |