The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Vancomycin (vanc) Method.
| Device ID | K892900 |
| 510k Number | K892900 |
| Device Name: | ACA VANCOMYCIN (VANC) METHOD |
| Classification | Radioimmunoassay, Vancomycin |
| 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 | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-05-22 |