510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800322Substantially Equivalent

Volu-Sol Ea-50 Stain

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

K800322 is the FDA 510(k) clearance record for VOLU-SOL EA-50 STAIN, a class I device, cleared for Volu Sol Medical Industries on under FDA product code HZJ (Stain, Papanicolau). FDA records list 66 510(k) clearances for Volu Sol Medical Industries, from to . As of , FDA records show no recalls naming K800322.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HZJ Stain, Papanicolau
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 HZJ

Trailing 12 months

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

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