510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193613Substantially Equivalent

Allergen-Specific IgE Assay 12 Allergen Bundle

Canon Medical Diagnostics USA, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K193613 is the FDA 510(k) clearance record for Allergen-Specific IgE Assay 12 Allergen Bundle, a class II device, cleared for Hitachi Chemical Diagnostics, Inc. on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 16 510(k) clearances for Canon Medical Diagnostics USA, Inc., from to . As of , FDA records show no recalls naming K193613.

Clearance record

Decision date
Received
(662 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Hitachi Chemical Diagnostics, Inc. 630 Clyde Ct., Mountain View CA
510(k) summary
Statement
Third party review
No

Clearances, product code DHB

Trailing 12 months
7 clearances under product code DHB in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DHB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20262
August 20260
September 20261
October 20260