The following data is part of a premarket notification filed by Alfa Wassermann with the FDA for Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-l Reagent.
| Device ID | K113436 |
| 510k Number | K113436 |
| Device Name: | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 |
| Product Code | CJE |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CIJ |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-07-12 |
| Summary: | summary |