The following data is part of a premarket notification filed by Alfa Wassermann with the FDA for Ace -gt Reagent; Ace Lipase Ragent; Ace T4 Reagent.
| Device ID | K131515 |
| 510k Number | K131515 |
| Device Name: | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 |
| Contact | Hyman Katz, Ph.d. |
| Correspondent | Hyman Katz, Ph.d. ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 |
| Product Code | KLI |
| Subsequent Product Code | CHI |
| Subsequent Product Code | JPZ |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-28 |
| Decision Date | 2013-08-14 |
| Summary: | summary |