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 Pseudocholinesterase Verifier.
| Device ID | K883891 |
| 510k Number | K883891 |
| Device Name: | DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER |
| Classification | Drug Specific Control Materials |
| 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 | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-14 |
| Decision Date | 1988-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005077 | K883891 | 000 |