The following data is part of a premarket notification filed by Alfa Wassermann Diagnostics Technologies, Llc with the FDA for Ace Bun/urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace Ck Reagent.
| Device ID | K123322 |
| 510k Number | K123322 |
| Device Name: | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz Ph.d. |
| Correspondent | Hyman Katz Ph.d. ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | CDN |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-05-21 |
| Summary: | summary |