510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803304Substantially Equivalent

Acridine Orange Stain

Remel Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803304 is the FDA 510(k) clearance record for ACRIDINE ORANGE STAIN, a class I device, cleared for Remel Co. on under FDA product code IDC (Acridine Orange). FDA records list 51 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K803304.

Clearance record

Decision date
Received
(44 days to decision)
Product code
IDC Acridine Orange
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Remel Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IDC

Trailing 12 months

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

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