510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991409Substantially Equivalent

K-Assay Rheumatoid Factor

Kamiya Biomedical Company, LLC, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991409 is the FDA 510(k) clearance record for K-ASSAY RHEUMATOID FACTOR, a class II device, cleared for Kamiya Biomedical Co. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 46 510(k) clearances for Kamiya Biomedical Co., from to . As of , FDA records show no recalls naming K991409.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Kamiya Biomedical Co. 910 Industry Dr., Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code DHR

Trailing 12 months

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

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