Atlas FDA

KQJ

28 FDA 510(k) clearances · Product code

60 daysmedian time to decision
157 days90th percentile
28clearances measured

FDA profile

Official device name
System, Fibrinogen Determination
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7340
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968)Instrumentation Laboratory (IL) Co.2025-07-24
HEMOSIL FIBRINOGEN-C (K073367)Instrumentation Laboratory CO2007-12-27
DADE THROMBIN REAGENT (K050928)Dade Behring, Inc.2005-06-29
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858)Sigma Diagnostics, Inc.1997-10-09
FIF TM (K970189)Panbio, Inc.1997-05-21
N-ASSAY TIA FIBRINOGEN TEST KIT (K965113)Crestat Diagnostics, Inc.1997-04-16
MULTIFIBREN U (K934326)Behring Diagnostics, Inc.1994-04-19
IL TEST FIBRINOGEN-C (K931721)Instrumentation Laboratory CO1993-08-13
FIBRINOGEN RID TEST KIT (K922416)The Binding Site, Ltd.1993-03-09
MULTIFIBREN (K925988)Behring Diagnostics, Inc.1993-03-01
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (K923593)International Technidyne Corp.1992-09-22
QBC FIBRINOGEN (K920258)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-06-26
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) (K900939)Incstar Corp.1990-05-16
COAG-A-MATE - RA4 (K900895)Organon Teknika Corp.1990-04-16
FIBRINOGEN ASSAY KIT (K896052)Medical Diagnostic Technologies, Inc.1989-11-09
TURBOX FIBRINOGEN (K884179)Unipath , Ltd.1988-12-20
DIA FIBRIN (K841366)Diatech, Inc.1984-06-01
FIBRINOGEN ASSAY KIT (K841020)Helena Laboratories1984-05-02
FIBRI-PREST AUTOMATE HA34 (K840211)Wellcome Diagnostics1984-03-02
FIBRINOGEN TEST (K834571)Diatech, Inc.1984-02-04
ACA FIBRINOGEN TEST PACK (K812629)E.I. Dupont DE Nemours & Co., Inc.1981-10-08
LABCER FIBRINOGEN ASSAY KIT & CALIBR. (K812570)Sherwood Medical Co.1981-10-02
LOW FIBRINOGEN CONTROL (K812108)Bio/Data Corp.1981-09-24
FIBRINOGEN CONTROL PLASMA (K811069)American Dade1981-07-10
ORTHO QUANTITATIVE FIBRINOGEN ASSAY (K810058)Ortho Diagnostic Systems, Inc.1981-02-26
SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA (K801926)Sigma Chemical Co.1980-09-09
FIBRINOGEN SCREEN (K800826)Pacific Hemostasis1980-05-30
THROMBOKINETIC FIBRINOGEN ASSAY (K792563)Bio/Data Corp.1980-01-11

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