The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Control Sera Level Values (mg/dl).
Device ID | K861567 |
510k Number | K861567 |
Device Name: | CONTROL SERA LEVEL VALUES (MG/DL) |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Contact | R. M Vaught |
Correspondent | R. M Vaught E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-28 |
Decision Date | 1986-05-23 |