The following data is part of a premarket notification filed by Alfa Wassermann with the FDA for Ace Alt Reagent.
| Device ID | K113382 |
| 510k Number | K113382 |
| Device Name: | ACE ALT REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| Subsequent Product Code | CIT |
| Subsequent Product Code | JPZ |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006563 | K113382 | 000 |
| 00857969006556 | K113382 | 000 |
| 00857969006686 | K113382 | 000 |
| 00857969006679 | K113382 | 000 |
| 00857969006662 | K113382 | 000 |