The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay.
| Device ID | K951851 |
| 510k Number | K951851 |
| Device Name: | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Antigen, Iha, Cytomegalovirus |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | James E Keller |
| Correspondent | James E Keller E.I. DUPONT DE NEMOURS & CO., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LJO |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-21 |
| Decision Date | 1996-07-24 |