510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K944738Substantially Equivalent

Series 600 Centrifuge-Four Separate Variations of the Same Base Centrifuge

Ducker CL, Sunrise FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944738 is the FDA 510(k) clearance record for SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE, a class I device, cleared for Ducker CL on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list one 510(k) clearance for Ducker CL. As of , FDA records show no recalls naming K944738.

Clearance record

Decision date
Received
(23 days to decision)
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ducker CL 4507 NW 103rd Ave., Sunrise FL
510(k) summary
Statement
Third party review
No

Clearances, product code JQC

Trailing 12 months

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

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