Atlas FDA

GJA

20 FDA 510(k) clearances · Product code

83 daysmedian time to decision
256 days90th percentile
20clearances measured

FDA profile

Official device name
Test, Thrombin Time
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7875
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
T-TEK (K050817)R2 Diagnostics, Inc.2005-12-12
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (K982209)Sigma Diagnostics, Inc.1998-10-15
BC THROMBIN REAGENT (K970645)Behring Diagnostics, Inc.1997-05-19
BIOMERIEUX HEMOLAB THROMBICALCI-TEST (K925493)Biomerieux Vitek, Inc.1994-04-21
TEST THROMBIN (K930157)Behring Diagnostics, Inc.1993-05-14
THROMBIN CLOT TIME TEST PROCEDURE (K923220)Medical Laboratory Automation Systems, Inc.1992-09-29
THROMBIN CLOTTING TIME REAGENT (K920147)Helena Laboratories1992-05-01
TT AND HNTT BY HEMOCHRON (K900126)International Technidyne Corp.1990-02-05
THROMBIN TIME REAGENT (K894467)Sigma Chemical Co.1989-09-05
FIBRI-PREST/THROMBIN-PREST CONTROLS (K884385)American Bioproducts Co.1988-12-28
THROMBIN-PREST REAGENT KIT (K884384)American Bioproducts Co.1988-12-28
IL SYSTEM 810, ACL AND THE REAGENT SETS (K862301)Instrumentation Laboratory CO1986-09-03
THROMBINEX BOVINE THROMBIN (K845000)Bio/Data Corp.1985-03-26
BOVINE THROMBIN, HUMAN THROMBIN (K841956)Haemachem, Inc.1984-07-19
THROMBOLYTIC ACTIVITY TEST (K834301)Bio/Data Corp.1984-02-04
THROMBIN TIME TEST (K822466)American Dade1982-09-14
THROMBIN CLOTTING TIME (K811109)Bio/Data Corp.1981-07-16
FIBRI QUIK (K802117)General Diagnostics1980-09-26
THROMBOQUIK THROMBIN REAGENT PROD. #3551 (K800926)General Diagnostics1980-05-08
HEPARSORB (K781781)General Diagnostics1979-01-10

Track GJA automatically

Every clearance here is in the API, with alerts when new ones post.