510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890984Substantially Equivalent

Linistain Sls

Shandon, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890984 is the FDA 510(k) clearance record for LINISTAIN SLS, a class I device, cleared for Shandon, Inc. on under FDA product code KIO (Slide Stainer, Immersion Type). FDA records list 5 510(k) clearances for Shandon, Inc., from to . As of , FDA records show no recalls naming K890984.

Clearance record

Decision date
Received
(36 days to decision)
Product code
KIO Slide Stainer, Immersion Type
Regulation
21 CFR 864.3800
Device class
Class I
Review panel
Pathology
Applicant
Shandon, Inc. 171 Industry Dr., Pittsburgh PA
Third party review
No

Clearances, product code KIO

Trailing 12 months

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

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