The following data is part of a premarket notification filed by Elias Usa, Inc. with the FDA for Syn Elisa Micro Albumin.
| Device ID | K920216 |
| 510k Number | K920216 |
| Device Name: | SYN ELISA MICRO ALBUMIN |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann |
| Correspondent | Gottfried Kellermann ELIAS USA, INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-16 |
| Decision Date | 1992-03-11 |