The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Cholesterol Reagent, Ace Hdl-c Reagent, Ace Ldl-c Reagent, Ace Triglycerides Reagent.
| Device ID | K112538 |
| 510k Number | K112538 |
| Device Name: | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-03-29 |
| Summary: | summary |