510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991439Substantially Equivalent

Poller Calibrants

European Concerted Action on Anticoagulation, Manchester, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991439 is the FDA 510(k) clearance record for POLLER CALIBRANTS, a class II device, cleared for European Concerted Action on Anticoagulation on under FDA product code GGN (Plasma, Coagulation Control). FDA records list one 510(k) clearance for European Concerted Action on Anticoagulation. As of , FDA records show no recalls naming K991439.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
European Concerted Action on Anticoagulation Oxford Rd., Manchester, GB
510(k) summary
Statement
Third party review
No

Clearances, product code GGN

Trailing 12 months

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

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