510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901674Substantially Equivalent

Aia-600 Automated Enzyme Immunoassay System

Tosoh Corp., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901674 is the FDA 510(k) clearance record for AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM, a class I device, cleared for Tosoh Corp. on under FDA product code KHO (Fluorometer, For Clinical Use). FDA records list 9 510(k) clearances for Tosoh Corp., from to . As of , FDA records show no recalls naming K901674.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KHO Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Tosoh Corp. Columbia Sq., Washington, D.C. DC
Third party review
No

Clearances, product code KHO

Trailing 12 months

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

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