Atlas FDA

JBQ

56 FDA 510(k) clearances · Product code

65 daysmedian time to decision
220 days90th percentile
56clearances measured

FDA profile

Official device name
Antithrombin Iii Quantitation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7060
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
INNOVANCE Antithrombin (K242952)Siemens Healthcare Diagnostic Products GmbH2025-03-28
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769)Siemens Healthcare Diagnostics2009-05-28
HEMOSIL ANTITHROMBIN (K070301)Instrumentation Laboratory CO2007-02-23
HEMOSIL LIQUID ANTITHROMBIN (K062431)Instrumentation Laboratory CO2006-09-01
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 (K043007)Hyphen Biomed2005-11-07
HEMOSIL LIQUID ANTITHROMBIN XL (K033775)Instrumentation Laboratory CO2004-01-02
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991)Precision Biologic2003-04-28
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
COAMATIC AT-400 (K022195)Instrumentation Laboratory CO2002-08-07
IL TEST LIQUID ANTITHROMBIN (K994238)Instrumentation Laboratory CO2000-06-23
K-ASSAY AT-III (K000361)Kamiya Biomedical Co.2000-04-26
IL TEST ANTITHROMBIN (K980499)Instrumentation Laboratory CO1998-04-02
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (K974110)Beckman Instruments, Inc.1997-12-24
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III (K972144)Sigma Diagnostics, Inc.1997-07-25
SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (K960871)Medical Diagnostic Technologies, Inc.1996-08-14
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY (K952515)Chromogenix AB1996-01-23
CHROM Z CHROMOGENIC ASSAYS (K951943)Helena Laboratories1995-11-13
AT-III CALIBRATOR (K944279)American Bioproducts Co.1995-04-07
BIOMERIEUX HEMOLAB AT III (K934156)Biomerieux Vitek, Inc.1994-12-22
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY (K935308)Sigma Diagnostics, Inc.1994-05-17
ANTITHROMBIN III CHROMOGENIC ASSAY (K936196)Baxter Diagnostics, Inc.1994-05-04
COATEST(R) ANTITHROMBIN III, MODIFICATION (K931420)Kabi Pharmacia Hepar, Inc.1994-05-02
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY (K915083)Kabi Pharmacia, Inc.1992-01-03
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT (K913667)The Binding Site, Ltd.1992-01-03
LIATEST(R) AT III TEST KIT (K905110)American Bioproducts Co.1991-01-24
COACUTE ANTITHROMBIN CHROMOGENIC ASSAY (K902393)Kabi Diagnostica1990-09-25
SPECTROLYSE ATIII KIT (K902530)Biopool AB1990-08-09
BECKMAN ANTITHROMBIN III REAGENT KIT (K901977)Beckman Instruments, Inc.1990-08-06
ORTHOKROME* ANTITHROMBIN (K900400)Ortho Diagnostic Systems, Inc.1990-03-15
ACTICHROME ATIII KIT (K893608)American Diagnostic Corp.1989-06-23
TURBOX ANTITHROMBIN III (K884144)Unipath , Ltd.1988-12-20
BERICHROM(R) ANTITHROMBIN III (K883662)Behring Diagnostics, Inc.1988-11-23
ENZYGNOST(R) TAT REAGENTS (K880700)Behring Diagnostics, Inc.1988-04-27
DADE ANTITHROMBIN III CHROMOGENIC ASSAY (K880315)Baxter Healthcare Corp1988-03-16
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY (K864214)Instrumentation Laboratory CO1986-11-25
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY (K850412)Warner-Lambert Co.1985-05-08
IL TEST ANTITHROMBIN III ACTIVITY (K841736)Instrumentation Laboratory CO1984-09-06
DIACROM * ATIII (K832592)Wellcome Diagnostics1983-09-29
RABBIT ANTI-HUMAN ANTITHROMBIN III (K832268)Gelco Diagnostics, Inc.1983-08-12
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (K831961)Kent Laboratories, Inc.1983-08-11
PROTOTRO/PROTEOLYTIC ENZYME CONTROL (K831297)American Dade1983-06-08
COATEST ANTITHROMBIN (K812829)Kabivitrum, Inc.1981-12-30
ACA ANTITHROMBIN III PLASMINOGEN CALIB (K812626)E.I. Dupont DE Nemours & Co., Inc.1981-11-24
ACA ANTITHROMBIN III TEST PACK (K812627)E.I. Dupont DE Nemours & Co., Inc.1981-10-08
ANTITHROMBIN III SCREEN KIT (K812215)Pacific Hemostasis1981-09-01
HELENA AT-III QUIPLATE PROCEDURE (K802912)Helena Laboratories1980-12-22
PHADECODE XA INHIBITOR ASSAY (K792019)Pharmaseal Div., Baxter Healthcare Corp.1979-11-05
DETERMINATION OF ANTITHROMBIN III, 885 (K790090)Sigma Chemical Co.1979-02-26
ASSAY, CHROMOGENIC ANTITHROMBIN III (K781860)Ortho Diagnostics, Inc.1978-12-04
ANTITHROMBIN III ASSAY (K781480)Dade, Baxter Travenol Diagnostics, Inc.1978-11-08
ANTITHROMBIN III SERUM, ANTI-HUMAN (K781026)Icl Scientific1978-08-10
LAS-R HUMAN ANTITHROMBIN III TEST (K772328)Hyland Therapeutic Div., Travenol Laboratories1978-02-03
ANTITHROMBIN III ASSAY (K780002)Ortho Diagnostics, Inc.1978-01-31
DIAG. KIT FOR TOTAL ANTITHROMBIN III (K771669)Abbott Laboratories1977-11-09
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY (K770942)Pharmaseal Div., Baxter Healthcare Corp.1977-07-21
THROMBO-SCREEN AT-111 KIT (K770394)Bay Area Hema. Onco. Clinic. & Res. L1977-03-30

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