The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Llc with the FDA for Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent.
| Device ID | K131351 |
| 510k Number | K131351 |
| Device Name: | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Product Code | CJE |
| Subsequent Product Code | CIJ |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CKA |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-08-15 |
| Summary: | summary |