510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800656Substantially Equivalent

A-Gent Quantichrom Thrombigen-E

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800656 is the FDA 510(k) clearance record for A-GENT QUANTICHROM THROMBIGEN-E, a class II device, cleared for Abbott Laboratories on under FDA product code GGQ (Test, Prothrombin Consumption). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K800656.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GGQ Test, Prothrombin Consumption
Regulation
21 CFR 864.7720
Device class
Class II
Review panel
Hematology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code GGQ

Trailing 12 months

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

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