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
K113438Substantially Equivalent

Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent

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

K113438 is the FDA 510(k) clearance record for ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT, a class I device, cleared for Alfa Wassermann Diagnostic Technologies, Inc. on under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity). FDA records list 23 510(k) clearances for Alfa Wassermann Diagnostic Technologies, Inc., from to . As of , FDA records show no recalls naming K113438.

Clearance record

Decision date
Received
(193 days to decision)
Product code
JMO Ferrozine (Colorimetric) Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Alfa Wassermann Diagnostic Technologies, Inc. 4 Henderson Dr., West Caldwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JMO

Trailing 12 months

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

FDA records show no clearances under product code JMO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JMO, 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