510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862141Substantially Equivalent

Histology Paraffin

Erie Scientific Co., Portsmouth NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862141 is the FDA 510(k) clearance record for HISTOLOGY PARAFFIN, a class I device, cleared for Erie Scientific Co. on under FDA product code KEO (Formulations, Paraffin, All). FDA records list one 510(k) clearance for Erie Scientific Co. As of , FDA records show no recalls naming K862141.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KEO Formulations, Paraffin, All
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Erie Scientific Co. Portsmouth Industrial Park, Portsmouth NH
Third party review
No

Clearances, product code KEO

Trailing 12 months

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

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