The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Urea Nitrogen Reagent, Calcium-arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.v. Reagent,urine Standard.
| Device ID | K103615 |
| 510k Number | K103615 |
| Device Name: | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | CDN |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CJY |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-09 |
| Decision Date | 2011-09-08 |
| Summary: | summary |