The following data is part of a premarket notification filed by Alfa Wassermann Diagnostics Technologies, Llc with the FDA for Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-arsenazo Reagent And Ace Phosphorus Reagent.
| Device ID | K131488 |
| 510k Number | K131488 |
| Device Name: | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | CIX |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CJY |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-23 |
| Decision Date | 2013-08-19 |
| Summary: | summary |