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Microbiology

3,049 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN (N50510/S108)Biomerieux Vitek, Inc.2000-01-24
VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN (N50510/S107)Biomerieux Vitek, Inc.2000-01-21
VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN (N50510/S106)Biomerieux Vitek, Inc.2000-01-10
VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN (N50510/S104)Biomerieux Vitek, Inc.2000-01-06
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN (N50510/S096)Biomerieux Vitek, Inc.1999-12-10
VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN (N50510/S102)Biomerieux Vitek, Inc.1999-12-10
VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN (N50510/S101)Biomerieux Vitek, Inc.1999-12-10
VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM (N50510/S097)Biomerieux Vitek, Inc.1999-12-03
VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN (N50510/S099)Biomerieux Vitek, Inc.1999-11-15
VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM (N50510/S093)Biomerieux Vitek, Inc.1999-11-10
VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE (N50510/S103)Biomerieux Vitek, Inc.1999-11-10
VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN (N50510/S095)Biomerieux Vitek, Inc.1999-11-08
VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S092)Biomerieux Vitek, Inc.1999-11-05
VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN (N50510/S098)Biomerieux Vitek, Inc.1999-11-05
VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN (N50510/S094)Biomerieux Vitek, Inc.1999-10-07
GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST (P940034/S008)Gen-Probe, Inc.1999-09-30
VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN (N50510/S091)Biomerieux Vitek, Inc.1999-09-23
VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN (N50510/S090)Biomerieux Vitek, Inc.1999-09-17
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S007)Gen-Probe, Inc.1999-09-02
BIOTRIN PARVOVIRUS B19 IGG (P970054)Diasorin1999-08-06
BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) (P970055)Diasorin1999-08-06
VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN (N50510/S089)Biomerieux Vitek, Inc.1999-07-26
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE (N50510/S088)Biomerieux Vitek, Inc.1999-07-12
VITEK 2 SYSTEM (N50510/S085)Biomerieux Vitek, Inc.1999-07-09
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM (N50510/S087)Biomerieux Vitek, Inc.1999-07-09
VITEK 2 SYSTEM (N50510/S084)Biomerieux Vitek, Inc.1999-06-28
VITEK 2 SYSTEM (N50510/S086)Biomerieux Vitek, Inc.1999-06-24
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029)Dade Intl., Inc.1999-06-24
VITEK 2 SYSTEM (N50510/S082)Biomerieux Vitek, Inc.1999-06-16
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S010)Gen-Probe, Inc.1999-05-25
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS (P980046)Pwn Health Chicago, LLC1999-04-28
HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY) (P890064/S006)Qiagen Gaithersburg, Inc.1999-03-17
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S028)Dade Intl., Inc.1999-01-25
AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST (P940034/S009)Gen-Probe, Inc.1998-12-01
AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS (P890019/S005)Diasorin1998-09-22
DIASORIN ETI-HA-IGMK PLUS (P890014/S002)DiaSorin, Inc.1998-09-16
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S083)Biomerieux Vitek, Inc.1998-09-15
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL) (N50510/S081)Biomerieux Vitek, Inc.1998-08-14
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027)Dade Intl., Inc.1998-06-30
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S004)Gen-Probe, Inc.1998-05-15
IMX(R) HAVAB (P780012/S008)Abbott Laboratories1998-05-12
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S080)Biomerieux Vitek, Inc.1998-04-14
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S005)Gen-Probe, Inc.1998-01-07
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S079)Biomerieux Vitek, Inc.1997-12-08
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S078)Biomerieux Vitek, Inc.1997-12-08
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S006)Gen-Probe, Inc.1997-10-30
HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S005)Qiagen Gaithersburg, Inc.1997-08-15
ABBOTT IMX(R) HAVAB(R)-M (P790019/S010)Abbott Laboratories1997-07-24
ABBOTT IMX(R) HAVAB(R)-M (P790019/S009)Abbott Laboratories1997-05-28
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S077)Biomerieux Vitek, Inc.1997-04-24
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S075)Biomerieux Vitek, Inc.1997-04-24
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S076)Biomerieux Vitek, Inc.1997-03-27
ABBOTT IMX(R) HAVAB(R)-M (P790019/S008)Abbott Laboratories1997-03-27
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S074)Biomerieux Vitek, Inc.1997-03-17
ABBOTT ANTI-DELTA EIA (P850062/S002)Abbott Laboratories1997-02-26
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S073)Biomerieux Vitek, Inc.1997-02-19
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S072)Biomerieux Vitek, Inc.1997-02-19
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S071)Biomerieux Vitek, Inc.1996-12-20
AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST (P940040)Roche Molecular Systems, Inc.1996-11-26
HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S004)Qiagen Gaithersburg, Inc.1996-08-28
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S003)Gen-Probe, Inc.1996-08-22
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S069)Biomerieux Vitek, Inc.1996-08-07
BARTELS CHEMORESPONSE ASSAY (P940036)Bartels Prognostics, Inc.1996-08-01
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S002)Gen-Probe, Inc.1996-06-05
HAVAB-M DIAGNOSTIC KIT (P790019/S006)Abbott Laboratories1996-05-29
HAVAB-M EIA DIAGNOSTIC KIT (P790019/S007)Abbott Laboratories1996-05-29
ABBOTT HBE (RDNA) EIA (P790025/S006)Abbott Laboratories1996-05-17
MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025)Dade Intl., Inc.1996-05-03
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S001)Gen-Probe, Inc.1996-04-23
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S070)Biomerieux Vitek, Inc.1996-04-22
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024)Dade Intl., Inc.1996-03-12
ABBOTT HBE (RDNA) EIA TEST KIT (P790025/S007)Abbott Laboratories1996-02-16
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S068)Biomerieux Vitek, Inc.1996-01-17
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034)Gen-Probe, Inc.1995-12-15
VITEK PIPERACILLIN/TAZOBACTAM (N50510/S064)Biomerieux Vitek, Inc.1995-11-27
VITEK LOMEFLOXACIN (N50510/S063)Biomerieux Vitek, Inc.1995-11-16
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S023)Dade Intl., Inc.1995-05-05
HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA (P890064/S003)Qiagen Gaithersburg, Inc.1995-04-28
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S067)Biomerieux Vitek, Inc.1995-04-19
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S061)Biomerieux Vitek, Inc.1995-03-01
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S057)Biomerieux Vitek, Inc.1995-02-23
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S065)Biomerieux Vitek, Inc.1994-12-14
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S022)Dade Intl., Inc.1994-12-08
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S066)Biomerieux Vitek, Inc.1994-11-03
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S021)Dade Intl., Inc.1994-10-04
IMX(R) HAVAB (P780012/S007)Abbott Laboratories1994-09-12
HAVAB-M DIAGNOSTIC KIT (P790019/S005)Abbott Laboratories1994-09-12
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S059)Biomerieux Vitek, Inc.1994-08-30
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S058)Biomerieux Vitek, Inc.1994-06-17
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064/S002)Qiagen Gaithersburg, Inc.1994-05-19
RAPID POSITIVE MIC PANEL (P870049/S018)Dade Intl., Inc.1994-05-09
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S020)Dade Intl., Inc.1994-02-10
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S052)Biomerieux Vitek, Inc.1993-06-24
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S005)Qiagen, Inc.1993-05-17
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064/S001)Qiagen Gaithersburg, Inc.1993-05-17
MICROSCAN(R) (P870049/S014)Dade Intl., Inc.1993-03-12
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S051)Biomerieux Vitek, Inc.1992-11-19
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S046)Biomerieux Vitek, Inc.1992-06-22
IMX(R) HAVAB (P780012/S006)Abbott Laboratories1992-03-09
MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS (P870049/S016)Dade Intl., Inc.1992-02-28
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