The following data is part of a premarket notification filed by Elias U.s.a., Inc. with the FDA for Syn Elisa Dsdna Antibodies.
| Device ID | K921132 |
| 510k Number | K921132 |
| Device Name: | SYN ELISA DSDNA ANTIBODIES |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottried Kellermann |
| Correspondent | Gottried Kellermann ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1992-12-01 |