The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu.
| Device ID | K072140 |
| 510k Number | K072140 |
| Device Name: | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU |
| Classification | Hexokinase, Glucose |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | David Slavin |
| Correspondent | David Slavin ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | CFR |
| Subsequent Product Code | CDN |
| Subsequent Product Code | JFM |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2008-06-24 |
| Summary: | summary |