The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent.
| Device ID | K123953 |
| 510k Number | K123953 |
| Device Name: | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz Ph.d. |
| Correspondent | Hyman Katz Ph.d. ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | KHS |
| Subsequent Product Code | CIG |
| Subsequent Product Code | JGJ |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-21 |
| Decision Date | 2013-05-02 |
| Summary: | summary |