510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820253Substantially Equivalent

Simul-Fer Serum Iron Test Kit

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

K820253 is the FDA 510(k) clearance record for SIMUL-FER SERUM IRON TEST KIT, a class I device, cleared for Diagnostic Reagents, Inc. on under FDA product code JJA (Radio-Labeled Iron Method, Iron (Non-Heme)). FDA records list 66 510(k) clearances for Diagnostic Reagents, Inc., from to . As of , FDA records show no recalls naming K820253.

Clearance record

Decision date
Received
(103 days to decision)
Product code
JJA Radio-Labeled Iron Method, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Reagents, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJA

Trailing 12 months

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

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