The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Added Use Claim For Dupont Aca Beta-2-microglobulin Test Pack.
| Device ID | K933648 |
| 510k Number | K933648 |
| Device Name: | ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-09-24 |