510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834396Substantially Equivalent

Direct Iron Reagent Set

Seragen Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834396 is the FDA 510(k) clearance record for DIRECT IRON REAGENT SET, a class I device, cleared for Seragen Diagnostics, Inc. on under FDA product code CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme)). FDA records list 20 510(k) clearances for Seragen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K834396.

Clearance record

Decision date
Received
(69 days to decision)
Product code
CFM Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Seragen Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CFM

Trailing 12 months

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

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