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Microbiology

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

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RecordFirmDate
MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS (P870049/S015)Dade Intl., Inc.1991-12-18
MICROSCAN(R) (P870049/S012)Dade Intl., Inc.1991-11-06
MICROSCAN(R) WALKAWAY(TM)-40 (P870049/S011)Dade Intl., Inc.1991-11-06
MICROSCAN(R) (P870049/S013)Dade Intl., Inc.1991-11-06
IMX(R) HAVAB (P780012/S005)Abbott Laboratories1991-10-25
ETI-HA-IGMK (P890014/S001)DiaSorin, Inc.1991-09-16
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S004)Qiagen, Inc.1991-08-19
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064)Qiagen Gaithersburg, Inc.1991-03-11
ETI-AB-HAVK (P890019/S001)Diasorin1991-03-01
EBK (P870048/S001)Diasorin1991-01-10
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S009)Dade Intl., Inc.1991-01-08
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S010)Dade Intl., Inc.1991-01-08
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S008)Dade Intl., Inc.1990-12-20
VITEK IMIPENUM CARD (N50510/S043)Biomerieux Vitek, Inc.1990-10-22
HAVAB-M DIAGNOSTIC KIT (P790019/S004)Abbott Laboratories1990-10-16
VITEK(R) AMPICILLIN/SULBACTAM (N50510/S044)Biomerieux Vitek, Inc.1990-10-04
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S045)Biomerieux Vitek, Inc.1990-09-24
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S005)Dade Intl., Inc.1990-08-03
VITEK MINOCYCLINE CARD (N50510/S042)Biomerieux Vitek, Inc.1990-08-03
HA-IGMK AND ETI-HA-IGMK (P890014)DiaSorin, Inc.1990-07-24
EBK (P870048)Diasorin1990-07-13
AB -HAVK (P890019)Diasorin1990-07-13
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S026)Abbott Laboratories1990-05-04
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001)Organon Teknika Corp.1990-03-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001)Organon Teknika Corp.1990-03-21
9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001)Organon Teknika Corp.1990-03-21
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S041)Biomerieux Vitek, Inc.1990-03-08
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S003)Qiagen, Inc.1990-02-01
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S004)Dade Intl., Inc.1990-01-22
AUTOBAC MIC TEST SYSTEM (N50524/S033)Organon Teknika Corp.1990-01-22
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S025)Abbott Laboratories1989-12-19
AUTOBAC MIC TEST SYSTEM (N50524/S035)Organon Teknika Corp.1989-12-07
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S023)Abbott Laboratories1989-11-16
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S003)Dade Intl., Inc.1989-10-03
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S024)Abbott Laboratories1989-09-25
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S002)Qiagen, Inc.1989-08-21
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S002)Dade Intl., Inc.1989-08-02
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S001)Qiagen, Inc.1989-06-06
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S040)Biomerieux Vitek, Inc.1989-04-12
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S001)Dade Intl., Inc.1989-03-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S021)Abbott Laboratories1989-03-10
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S022)Abbott Laboratories1989-03-09
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009)Qiagen, Inc.1988-12-23
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S039)Biomerieux Vitek, Inc.1988-12-22
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S020)Abbott Laboratories1988-11-10
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S038)Biomerieux Vitek, Inc.1988-11-01
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S037)Biomerieux Vitek, Inc.1988-10-24
AUTOBAC MIC TEST SYSTEM (N50524/S030)Organon Teknika Corp.1988-10-18
AUTOBAC MIC TEST SYSTEM (N50524/S029)Organon Teknika Corp.1988-09-26
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S036)Biomerieux Vitek, Inc.1988-09-26
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S035)Biomerieux Vitek, Inc.1988-09-07
AUTOBAC MIC TEST SYSTEM (N50524/S028)Organon Teknika Corp.1988-08-22
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S034)Biomerieux Vitek, Inc.1988-08-22
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S032)Biomerieux Vitek, Inc.1988-08-10
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S033)Biomerieux Vitek, Inc.1988-08-10
AUTOBAC MIC TEST SYSTEM (N50524/S027)Organon Teknika Corp.1988-07-21
AUTOBAC MIC TEST SYSTEM (N50524/S024)Organon Teknika Corp.1988-07-20
AUTOBAC MIC TEST SYSTEM (N50524/S025)Organon Teknika Corp.1988-07-07
AUTOBAC MIC TEST SYSTEM (N50524/S026)Organon Teknika Corp.1988-06-22
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S019)Abbott Laboratories1988-06-08
AUTOBAC MIC TEST SYSTEM (N50524/S023)Organon Teknika Corp.1988-04-20
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S017)Abbott Laboratories1988-04-20
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S018)Abbott Laboratories1988-04-20
AUTOBAC MIC TEST SYSTEM (N50524/S022)Organon Teknika Corp.1988-04-12
AUTOBAC MTS PLUS TEST SYTEM (P810024/S004)Warner-Lambert Co.1988-04-12
AUTOBAC MIC TEST SYSTEM (N50524/S021)Organon Teknika Corp.1988-04-05
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S017)Organon Teknika Corp.1988-04-05
MICROSCAN RAPID PANELS (P870049)Dade Intl., Inc.1988-02-24
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S031)Biomerieux Vitek, Inc.1988-01-13
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S015)Abbott Laboratories1988-01-11
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S016)Abbott Laboratories1988-01-11
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S030)Biomerieux Vitek, Inc.1987-12-17
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S029)Biomerieux Vitek, Inc.1987-11-17
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S015)Organon Teknika Corp.1987-08-10
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S016)Organon Teknika Corp.1987-08-10
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S028)Biomerieux Vitek, Inc.1987-07-20
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S027)Biomerieux Vitek, Inc.1987-07-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S014)Abbott Laboratories1987-07-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S013)Abbott Laboratories1987-07-16
AMS CEFOTETAN CARD (N50510/S026)Biomerieux Vitek, Inc.1987-07-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S012)Abbott Laboratories1987-04-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S011)Abbott Laboratories1987-04-16
AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S003)Sorin Biomedica, Fiat, USA, Inc.1987-02-17
ABBOTT HBE DIAGNOSTIC KIT (P790025/S004)Abbott Laboratories1986-11-14
AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S002)Sorin Biomedica, Fiat, USA, Inc.1986-10-31
AMS CEFOTETAN CARD (N50510/S025)Biomerieux Vitek, Inc.1986-09-29
AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S001)Sorin Biomedica, Fiat, USA, Inc.1986-08-26
ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA) (P850062/S001)Abbott Laboratories1986-07-29
ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA) (P850062)Abbott Laboratories1986-07-01
COBAS BACT (P840065)Roche Diagnostics GmbH1986-05-30
AMMENDMENT TO E. COLI ASC (N50510/S024)Biomerieux Vitek, Inc.1986-05-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070)Organon Teknika Corp.1986-05-14
AMMENDMENT TO E. COLI ASC (N50510/S023)Biomerieux Vitek, Inc.1986-03-27
AUTOBAC MTS PLUS TEST SYTEM (P810024/S003)Warner-Lambert Co.1986-03-17
AUTOBAC MIC TEST SYSTEM (N50524/S020)Organon Teknika Corp.1986-03-17
AUTOBAC MTS PLUS TEST SYTEM (P810024/S002)Warner-Lambert Co.1986-03-17
AMMENDMENT TO E. COLI ASC (N50510/S022)Biomerieux Vitek, Inc.1986-02-28
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