The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Vista(r) Immunoassay System.
Device ID | K900245 |
510k Number | K900245 |
Device Name: | DU PONT VISTA(R) IMMUNOASSAY SYSTEM |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Roger C Briden |
Correspondent | Roger C Briden E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-17 |
Decision Date | 1990-04-11 |