510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832496Substantially Equivalent

Bio Sure Stain

Helena Laboratories, Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832496 is the FDA 510(k) clearance record for BIO SURE STAIN, a class I device, cleared for Helena Laboratories on under FDA product code IDA (Alcian Blue). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K832496.

Clearance record

Decision date
Received
(47 days to decision)
Product code
IDA Alcian Blue
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Helena Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IDA

Trailing 12 months

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

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