510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822128Substantially Equivalent

Volu-Sol Single Differential Stain

Volu Sol Medical Industries, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822128 is the FDA 510(k) clearance record for VOLU-SOL SINGLE DIFFERENTIAL STAIN, a class I device, cleared for Volu Sol Medical Industries on under FDA product code ICN (Biebrich Scarlet). FDA records list 66 510(k) clearances for Volu Sol Medical Industries, from to . As of , FDA records show no recalls naming K822128.

Clearance record

Decision date
Received
(17 days to decision)
Product code
ICN Biebrich Scarlet
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Volu Sol Medical Industries 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ICN

Trailing 12 months

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

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