The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Treponema Pallidum Treponemal Test Reagents; Quality Control Materials.
| Device ID | K112343 |
| 510k Number | K112343 |
| Device Name: | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-15 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599885 | K112343 | 000 |
| 00630414580173 | K112343 | 000 |
| 00630414599892 | K112343 | 000 |
| 00630414580616 | K112343 | 000 |