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
K091486Substantially Equivalent

K-Assay Microalbumin and K-Assay Microalbumin Calibrator

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

K091486 is the FDA 510(k) clearance record for K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR, a class II device, cleared for Kamiya Biomedical Co. on under FDA product code DCF (Albumin, Antigen, Antiserum, Control). FDA records list 46 510(k) clearances for Kamiya Biomedical Co., from to . As of , FDA records show no recalls naming K091486.

Clearance record

Decision date
Received
(345 days to decision)
Product code
DCF Albumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
Device class
Class II
Review panel
Immunology
Applicant
Kamiya Biomedical Co. 12779 Gateway Dr., Tukwila WA
510(k) summary
Statement
Third party review
No

Clearances, product code DCF

Trailing 12 months

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

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