510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894253Substantially Equivalent

Quidel Food Allergen Screen

Ortho-Clinical Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894253 is the FDA 510(k) clearance record for QUIDEL FOOD ALLERGEN SCREEN, a class II device, cleared for Quidel Corp. on under FDA product code DHB (System, Test, Radioallergosorbent (Rast) Immunological). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K894253.

Clearance record

Decision date
Received
(38 days to decision)
Product code
DHB System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Quidel Corp. 10165 Mckellar Ct., San Diego CA
Third party review
No

Clearances, product code DHB

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