510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080595Substantially Equivalent

Cellavision Dm96 with the Body Fluid Application

Cellavision AB, Minneapolis, MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080595 is the FDA 510(k) clearance record for CELLAVISION DM96 WITH THE BODY FLUID APPLICATION, a class II device, cleared for CellaVision AB on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list 7 510(k) clearances for CellaVision AB, from to . As of , FDA records show no recalls naming K080595.

Clearance record

Decision date
Received
(277 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
CellaVision AB 6740 Riverview Ter., Minneapolis, MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOY

Trailing 12 months

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

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