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(r) Salicylate(sal) Method.
Device ID | K904301 |
510k Number | K904301 |
Device Name: | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD |
Classification | Colorimetry, Salicylate |
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 | DKJ |
CFR Regulation Number | 862.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-19 |
Decision Date | 1990-11-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768005435 | K904301 | 000 |