510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954591Substantially Equivalent

Aia-Pack Cort Assay

Tosoh Medics, Inc., Foster City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954591 is the FDA 510(k) clearance record for AIA-PACK CORT ASSAY, a class II device, cleared for Tosoh Medics, Inc. on under FDA product code JFT (Fluorometric, Cortisol). FDA records list 41 510(k) clearances for Tosoh Medics, Inc., from to . As of , FDA records show one recall naming K954591.

Clearance record

Decision date
Received
(74 days to decision)
Product code
JFT Fluorometric, Cortisol
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tosoh Medics, Inc. 373 D Vintage Park Dr., Foster City CA
510(k) summary
Statement
Third party review
No

Clearances, product code JFT

Trailing 12 months

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

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