510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030528Substantially Equivalent

Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/dl)

Clinical Data, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030528 is the FDA 510(k) clearance record for ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL), a class I device, cleared for Clinical Data on under FDA product code JIY (Photometric Method, Iron (Non-Heme)). FDA records list 37 510(k) clearances for Clinical Data, from to . As of , FDA records show no recalls naming K030528.

Clearance record

Decision date
Received
(118 days to decision)
Product code
JIY Photometric Method, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Clinical Data 1075 W. Lambert Rd., Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIY

Trailing 12 months

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

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