510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853025Substantially Equivalent

Image-Ige

Clinical Reference Laboratory, Inc., Lenexa KA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853025 is the FDA 510(k) clearance record for IMAGE-IGE, a class II device, cleared for Clinical Reference Laboratory, Inc. on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Clinical Reference Laboratory, Inc. As of , FDA records show no recalls naming K853025.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Clinical Reference Laboratory, Inc. 11844 W. 85th St., Lenexa KA
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

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