510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992365Substantially Equivalent

Aia-Pack Folate Assay

Tosoh Medics, Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992365 is the FDA 510(k) clearance record for AIA-PACK FOLATE ASSAY, a class II device, cleared for Tosoh Medics, Inc. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 41 510(k) clearances for Tosoh Medics, Inc., from to . As of , FDA records show 2 recalls naming K992365.

Clearance record

Decision date
Received
(26 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tosoh Medics, Inc. 347 Oyster Pt. Blvd.,, South San Francisco CA
510(k) summary
Statement
Third party review
No

Clearances, product code CGN

Trailing 12 months

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

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