510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893663Substantially Equivalent

Instant Eosin-Aqueous

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

K893663 is the FDA 510(k) clearance record for INSTANT EOSIN-AQUEOUS, a class I device, cleared for Shandon, Inc. on under FDA product code HYB (Eosin Y). FDA records list 5 510(k) clearances for Shandon, Inc., from to . As of , FDA records show no recalls naming K893663.

Clearance record

Decision date
Received
(29 days to decision)
Product code
HYB Eosin Y
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Shandon, Inc. 171 Industry Dr., Pittsburgh PA
Third party review
No

Clearances, product code HYB

Trailing 12 months

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

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