510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993354Substantially Equivalent

K-Assay Apo B

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

K993354 is the FDA 510(k) clearance record for K-ASSAY APO B, a class II device, cleared for Kamiya Biomedical Co. on under FDA product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control). FDA records list 46 510(k) clearances for Kamiya Biomedical Co., from to . As of , FDA records show no recalls naming K993354.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5580
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 DER

Trailing 12 months

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

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