The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Lactate Dehydrogenase Isoenzyme 1 (ld1) Method.
| Device ID | K921455 |
| 510k Number | K921455 |
| Device Name: | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
| Product Code | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-04-29 |