510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964913Substantially Equivalent

Iron Reagent

Derma Media Lab., Inc., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964913 is the FDA 510(k) clearance record for IRON REAGENT, a class I device, cleared for Derma Media Lab., Inc. on under FDA product code JIY (Photometric Method, Iron (Non-Heme)). FDA records list 18 510(k) clearances for Derma Media Lab., Inc., from to . As of , FDA records show no recalls naming K964913.

Clearance record

Decision date
Received
(73 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
Derma Media Lab., Inc. 8531 Wellsford Pl., Suite E, Santa Fe Springs CA
510(k) summary
Statement
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