510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894416Substantially Equivalent

Raichem(tm) Spia(tm) Igg Reagents

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

K894416 is the FDA 510(k) clearance record for RAICHEM(TM) SPIA(TM) IGG REAGENTS, a class I device, cleared for Reagents Applications, Inc. on under FDA product code KTO (Reagent, Immunoassay, Igg). FDA records list 63 510(k) clearances for Reagents Applications, Inc., from to . As of , FDA records show no recalls naming K894416.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KTO Reagent, Immunoassay, Igg
Regulation
21 CFR 866.5530
Device class
Class I
Review panel
Immunology
Applicant
Reagents Applications, Inc. 8225 Mercury Ct., San Diego CA
Third party review
No

Clearances, product code KTO

Trailing 12 months

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

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