510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030590Substantially Equivalent

Cla Allergen-Specific Ige Assay-Latex Allergen (K82)

Canon Medical Diagnostics USA, Inc., Mountain View CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030590 is the FDA 510(k) clearance record for CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82), 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 K030590.

Clearance record

Decision date
Received
(24 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
Summary PDF
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