DeviceClearance

Product code GJA— Hematology

ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589

Classification name
Test, Thrombin Time
Device class
Class 2
Regulation
21 CFR 864.7875
Advisory panel
Hematology
Total cleared
20
First cleared
Most recent

Market context for product code GJA

FDA has cleared 20 devices under product code GJA between 1979 and 2005, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GJA

Recent clearances under product code GJA

Data sourced from openFDA. This site is unofficial and independent of the FDA.