Atlas FDA

GHH

28 FDA 510(k) clearances · Product code

97 daysmedian time to decision
549 days90th percentile
28clearances measured

FDA profile

Official device name
Fibrin Split Products
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7320
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 8 · 2017: 18 · 2018: 19 · 2019: 19 · 2020: 16 · 2021: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (K112120)Diazyme Laboratories2013-01-24
PATHFAST D-DIMER (K072288)Mitsubishi Kagaku Iatron2009-05-06
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL (K070453)Olympus Life & Material Science Europa GmbH (Irish2007-06-11
TINA-QUANT D-DIMER TEST SYSTEM (K062203)Roche Diagnostics Corp.2007-03-14
TRIAGE D-DIMER TEST, MODEL 98100 (K042890)Biosite Incorporated2004-11-29
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (K030740)Roche Diagnostics Corp.2003-04-01
MDA D-DIMER (K021877)bioMerieux, Inc.2002-08-07
TINA-QUANT D-DIMER TEST SYSTEM (K011143)Roche Diagnostics Corp.2001-05-29
SIMPLIFY D-DIMER, MODEL DCGK1 (K993276)Agen Biomedical , Ltd.1999-12-14
OPUS D-DIMER (K972316)Behring Diagnostics, Inc.1997-09-09
AGEN DIMERTEST GOLD EIA (K945642)Agen Biomedical , Ltd.1995-10-25
FDP - SLIDEX DIRECT (K921989)Biomerieux Vitek, Inc.1993-11-03
MINUTEX D-DIMER LATEX TEST (K920668)Biopool AB1992-10-16
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY (K905643)Agen Biomedical , Ltd.1991-04-12
ABBOTT IMX(TM) D-DIMER (K893961)Abbott Laboratories1989-08-03
ABBOTT TESTPACK(TM) D-DIMER (K890422)Abbott Laboratories1989-03-27
MODIFIED D-DI-TEST KIT (K890399)American Bioproducts Co.1989-02-07
FIBRINOSTICON (K880077)Organon Teknika Corp.1988-02-09
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (K872360)American Dade1987-07-06
D-DI TEST KIT (K861973)American Bioproducts Co.1986-09-04
FDP ASSAY-20 TEST KIT (K852848)American Bioproducts Co.1985-10-10
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK (K852520)E.I. Dupont DE Nemours & Co., Inc.1985-10-04
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT (K852512)Pacific Hemostasis1985-09-17
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR (K852176)E.I. Dupont DE Nemours & Co., Inc.1985-08-12
DIMERTEST LATEX (K842277)Mabco, Inc.1985-04-03
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN (K812298)Syn-Kit, Inc.1981-12-17
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) (K801841)American Hospital Supply Corp.1980-10-10
FIBRO-TEC TEST KIT (K791358)Calbiochem-Behring Corp.1979-09-04

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