510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850333Substantially Equivalent

Pump Tube Sets for Hema-Tek I & II Slide Stainers

Shaban Mfg. Co., Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850333 is the FDA 510(k) clearance record for PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS, a class I device, cleared for Shaban Mfg. Co. on under FDA product code KPA (Slide Stainer, Automated). FDA records list 35 510(k) clearances for Shaban Mfg. Co., from to . As of , FDA records show no recalls naming K850333.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KPA Slide Stainer, Automated
Regulation
21 CFR 864.3800
Device class
Class I
Review panel
Pathology
Applicant
Shaban Mfg. Co. 3052 Metro Pkwy., Fort Myers FL
Third party review
No

Clearances, product code KPA

Trailing 12 months

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

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