The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca(r) Lactic Dehydrogenase Isoenzyme 1 (ld1) Meth.
| Device ID | K905861 |
| 510k Number | K905861 |
| Device Name: | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-31 |
| Decision Date | 1991-02-06 |