510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120626Substantially Equivalent

Eon Calcium Regent

Vital Diagnostics (Manufacturing) Ptyltd, Noble Park, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K120626 is the FDA 510(k) clearance record for EON CALCIUM REGENT, a class II device, cleared for Vital Diagnostics (Manufacturing) Ptyltd on under FDA product code CJY (Azo Dye, Calcium). FDA records list 5 510(k) clearances for Vital Diagnostics (Manufacturing) Ptyltd, from to . As of , FDA records show 2 recalls naming K120626.

Clearance record

Decision date
Received
(174 days to decision)
Product code
CJY Azo Dye, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Vital Diagnostics (Manufacturing) Ptyltd 189-199 Browns Rd., Noble Park, AU
510(k) summary
Statement
Third party review
No

Clearances, product code CJY

Trailing 12 months

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

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