The following data is part of a premarket notification filed by Alfa Wassermann, Inc. with the FDA for S-test Cholesterol (cho), Model Rc0009, S-test Hdl Cholesterol (hdl), Model Rc0015, S-test Triglycerides (tg).
| Device ID | K091413 |
| 510k Number | K091413 |
| Device Name: | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-10-26 |
| Summary: | summary |