510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810848Substantially Equivalent

Cytobucket Model 1024

Cytochem, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810848 is the FDA 510(k) clearance record for CYTOBUCKET MODEL 1024, a class I device, cleared for Cytochem, Inc. on under FDA product code IFB (Cytocentrifuge). FDA records list one 510(k) clearance for Cytochem, Inc. As of , FDA records show no recalls naming K810848.

Clearance record

Decision date
Received
(27 days to decision)
Product code
IFB Cytocentrifuge
Regulation
21 CFR 864.3300
Device class
Class I
Review panel
Pathology
Applicant
Cytochem, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IFB

Trailing 12 months

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

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