510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122302Substantially Equivalent

Ace Magnesium Regent

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

K122302 is the FDA 510(k) clearance record for ACE MAGNESIUM REGENT, a class I device, cleared for Alfa Wassermann Diagnostics Technologies, LLC on under FDA product code JGJ (Photometric Method, Magnesium). FDA records list 3 510(k) clearances for Alfa Wassermann Diagnostics Technologies, LLC, from to . As of , FDA records show no recalls naming K122302.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JGJ Photometric Method, Magnesium
Regulation
21 CFR 862.1495
Device class
Class I
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 JGJ

Trailing 12 months

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

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