510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811534Substantially Equivalent

Hemaspinner

Geometric Data, Div. Smithkline Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811534 is the FDA 510(k) clearance record for HEMASPINNER, a class I device, cleared for Geometric Data, Div. Smithkline Corp. on under FDA product code GKJ (Spinner, Slide, Automated). FDA records list 18 510(k) clearances for Geometric Data, Div. Smithkline Corp., from to . As of , FDA records show no recalls naming K811534.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GKJ Spinner, Slide, Automated
Regulation
21 CFR 864.5850
Device class
Class I
Review panel
Hematology
Applicant
Geometric Data, Div. Smithkline Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GKJ

Trailing 12 months

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

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