The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca(r) Beta-2-microglobulin Calibrator.
| Device ID | K914225 |
| 510k Number | K914225 |
| Device Name: | ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-20 |
| Decision Date | 1991-11-22 |