The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Syn Ena Screen (pin Plate).
| Device ID | K940229 |
| 510k Number | K940229 |
| Device Name: | SYN ENA SCREEN (PIN PLATE) |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann,ph.d |
| Correspondent | Gottfried Kellermann,ph.d ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-18 |
| Decision Date | 1994-05-11 |