510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K123322Substantially Equivalent

Ace Bun/urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace Ck Reagent

Alfa Wassermann Diagnostics Technologies, LLC, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123322 is the FDA 510(k) clearance record for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT, a class II device, cleared for Alfa Wassermann Diagnostics Technologies, LLC on under FDA product code CDN (Urease, Photometric, Urea Nitrogen). FDA records list 3 510(k) clearances for Alfa Wassermann Diagnostics Technologies, LLC, from to . As of , FDA records show no recalls naming K123322.

Clearance record

Decision date
Received
(207 days to decision)
Product code
CDN Urease, Photometric, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alfa Wassermann Diagnostics Technologies, LLC 4 Henderson Dr., West Caldwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDN

Trailing 12 months

FDA records hold no clearances under product code CDN in the trailing twelve months.

FDA records show no clearances under product code CDN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260