510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882357Substantially Equivalent

Microscope Slides Precoated W/histogrip & Poly-Ly

Stat Path, Riderwood MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882357 is the FDA 510(k) clearance record for MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY, a class I device, cleared for Stat Path on under FDA product code KEW (Slides, Microscope). FDA records list 4 510(k) clearances for Stat Path, from to . As of , FDA records show no recalls naming K882357.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KEW Slides, Microscope
Regulation
21 CFR 864.3010
Device class
Class I
Review panel
Pathology
Applicant
Stat Path P.O. Box 6, Riderwood MD
Third party review
No

Clearances, product code KEW

Trailing 12 months

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

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