The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for S-test C-reactive Protein (crp).
| Device ID | K083040 |
| 510k Number | K083040 |
| Device Name: | S-TEST C-REACTIVE PROTEIN (CRP) |
| Classification | System, Test, C-reactive Protein |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Dennis Taschek |
| Correspondent | Dennis Taschek ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2009-01-30 |
| Summary: | summary |