510(k) K123322

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT by Alfa Wassermann Diagnostics Technologies, LLC — Product Code CDN

K123322 is an FDA 510(k) premarket notification submitted by Alfa Wassermann Diagnostics Technologies, LLC for the device "ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT". The FDA issued a decision of Substantially Equivalent on May 21, 2013. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Alfa Wassermann Diagnostics Technologies, LLC has at least 2 other 510(k) clearances on record.