510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844640Substantially Equivalent

Polystat, Biological Stain

Surgipath Medical Industries, Inc., Grayslake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844640 is the FDA 510(k) clearance record for POLYSTAT, BIOLOGICAL STAIN, a class I device, cleared for Surgipath Medical Industries, Inc. on under FDA product code IAB (Toluidine Blue). FDA records list 30 510(k) clearances for Surgipath Medical Industries, Inc., from to . As of , FDA records show no recalls naming K844640.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IAB Toluidine Blue
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Surgipath Medical Industries, Inc. P.O. Box 769, Grayslake IL
Third party review
No

Clearances, product code IAB

Trailing 12 months

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

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