510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K853241Substantially Equivalent

Hematology Stain Pack

Fisher Scientific Company L.L.C., Fair Lawn NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853241 is the FDA 510(k) clearance record for HEMATOLOGY STAIN PACK, a class I device, cleared for Fisher Scientific Co., LLC on under FDA product code IAF (Wright'S Stain). FDA records list 89 510(k) clearances for Fisher Scientific Co., LLC, from to . As of , FDA records show no recalls naming K853241.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IAF Wright'S Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Fisher Scientific Co., LLC 1 Reagent Ln., Fair Lawn NJ
Third party review
No

Clearances, product code IAF

Trailing 12 months

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

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