The following data is part of a premarket notification filed by Elias U.s.a., Inc. with the FDA for Synelisa Tg Antibodies/tpo Antibodies.
| Device ID | K933123 |
| 510k Number | K933123 |
| Device Name: | SYNELISA TG ANTIBODIES/TPO ANTIBODIES |
| Classification | Electrophoresis Instrumentation |
| Applicant | ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann |
| Correspondent | Gottfried Kellermann ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | JZS |
| CFR Regulation Number | 866.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1993-08-23 |