510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864819Substantially Equivalent

Raichem (Tm)serum Iron and Tibc Reagents

Reagents Applications, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864819 is the FDA 510(k) clearance record for RAICHEM (TM)SERUM IRON AND TIBC REAGENTS, a class I device, cleared for Reagents Applications, Inc. on under FDA product code JIY (Photometric Method, Iron (Non-Heme)). FDA records list 63 510(k) clearances for Reagents Applications, Inc., from to . As of , FDA records show no recalls naming K864819.

Clearance record

Decision date
Received
(65 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
Reagents Applications, Inc. 8225 Mercury Ct., San Diego CA
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