The following data is part of a premarket notification filed by Advanced Biological Products, Inc. with the FDA for Elisa-doxa Jo-1.
| Device ID | K924950 |
| 510k Number | K924950 |
| Device Name: | ELISA-DOXA JO-1 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | ADVANCED BIOLOGICAL PRODUCTS, INC. C/O SIMPLICITY DIAGNOSTICS P.O. BOX 730, 31 N. YORK RD. Hatboro, PA 19040 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman ADVANCED BIOLOGICAL PRODUCTS, INC. C/O SIMPLICITY DIAGNOSTICS P.O. BOX 730, 31 N. YORK RD. Hatboro, PA 19040 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-05-19 |