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Microbiology

6,936 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ETEST BENZYLPENICILLIN (K980335)Ab Biodisk1998-06-15
ETEST BENZYLPENICILLIN (K981135)Ab Biodisk1998-06-09
ETEST CEFOTAXIME (K981137)Ab Biodisk1998-06-09
ETEST FOSFOMYCIN (K981136)Ab Biodisk1998-06-09
CEFDINIR, 5 UG, SENSI-DISC (K981517)Becton Dickinson Microbiology Systems1998-06-09
ETEST CIPROFLOXACIN (K981138)Ab Biodisk1998-06-05
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) (K971007)Mrl Diagnostics1998-06-01
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) (K971006)Mrl Diagnostics1998-06-01
ETEST CEFTRIAXONE (K981139)Ab Biodisk1998-06-01
ETEST CHLORAMPHENICAL (K980342)Ab Biodisk1998-05-29
ETEST VANCOMYCIN (K980348)Ab Biodisk1998-05-29
ETEST TETRACYCLINE (K981134)Ab Biodisk1998-05-28
ETEST OFLOXACIN (K980338)Ab Biodisk1998-05-28
ETEST TETRACYCLINE (K980347)Ab Biodisk1998-05-27
ETEST CEFTRIAXONE (K980345)Ab Biodisk1998-05-27
CRYPTOSPORIDIUM TEST (K980354)Techlab, Inc.1998-05-18
ETEST GREPAFLOXACIN (K980773)Ab Biodisk1998-05-18
PASCO MIC AND MIC/ID PANELS (K980955)Pasco Laboratories, Inc.1998-05-18
ETEST TROVAFLOXACIN (K980603)Ab Biodisk1998-05-13
PREMIER PLATINUM HPSA (K980076)Meridian Diagnostics, Inc.1998-05-12
BACTEC MGIT 960 SYSTEM (K974883)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-05-01
CMVGEN (K974456)Instrumentation Laboratory CO1998-05-01
TROVAFLOXACIN 10G, SENSI-DISC (K980683)Becton Dickinson Microbiology Systems1998-05-01
EBNA-1 IGM ELISA TEST SYSTEM (K980598)Clark Laboratories, Inc.1998-05-01
SERAQUEST MUMPS IGG (K980059)Quest Intl., Inc.1998-04-23
PROSPECT SHIGA TOXIN MICROPLATE ASSAY (K980507)Alexon - Trend, Inc.1998-04-23
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) (K970761)Cambridge Diagnostics Ireland, Ltd.1998-04-09
HUMAN LYME IGM WESTERN BLOT KIT (K970768)Cambridge Diagnostics Ireland, Ltd.1998-04-09
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302)Light Diagnostics1998-04-08
PARA-PAK SPINCON (K980077)Meridian Diagnostics, Inc.1998-04-02
EA-D IGG ELISA TEST SYSTEM (K973123)Clark Laboratories, Inc.1998-03-26
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (K974881)Biosite Incorporated1998-03-20
SHIELD HELICO-G2 ELISA KIT (K972981)Shield Diagnostics, Ltd.1998-03-17
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) (K971591)David C. Bishop, Ph.D.1998-03-13
PYLORI DETECT IGG (K973508)Micro Detect, Inc.1998-03-10
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522)Abbott Laboratories1998-03-03
ACCUSTAT H. PYLORI ONE STEP TEST (K973523)Boehringer Mannheim Corp.1998-03-03
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM (K973000)Alimenterics, Inc.1998-02-26
GREPAFLOXACIN, 5 MG, SENSI-DISC (K974578)Becton Dickinson Microbiology Systems1998-02-23
URINE SCREENING DEVICE (K972676)Combact Diagnostic Systems , Ltd.1998-02-23
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) (K971169)Cambridge Biotech Corp.1998-02-17
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) (K971170)Cambridge Biotech Corp.1998-02-17
PASCO MIC AND MIC/ID PANELS (K974362)Pasco Laboratories, Inc.1998-02-12
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (K974810)Boston Biomedica, Inc.1998-02-05
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (K974809)Boston Biomedica, Inc.1998-02-05
BACTEC MYCO/F LYTIC CULTURE VIALS (K970333)Becton Dickinson Microbiology Systems1998-01-28
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971636)Oxoid , Ltd.1998-01-28
DIAMEDIX IS-MEASLES IGG TEST SYSTEM (K974552)Diamedix Corp.1998-01-28
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576)Accumed Intl., Inc.1998-01-22
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K974394)Oxoid , Ltd.1998-01-14
BACTEC MYCO/F LYTIC CULTURE VIALS (K970512)Becton Dickinson Microbiology Systems1998-01-08
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (K973457)Shared Systems, Inc.1998-01-02
QUANTA LITE REBELLA IGG (K971304)Inova Diagnostics, Inc.1998-01-02
WELLCOLEX E.COLI O157:H7 (K971663)Murex Biotech , Ltd.1997-12-30
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971637)Oxoid , Ltd.1997-12-23
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (K972406)Immunoprobe, Inc.1997-12-22
IMAGEN RESPIRATORY SCREEN (K973954)Dako Diagnostics , Ltd.1997-12-22
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (K974261)Boston Biomedica, Inc.1997-12-11
QUANTA LITE TOXOPLASMA IGG (K971441)Inova Diagnostics, Inc.1997-12-02
BACT/ALERT FAN CULTURE BOTTLES (K973325)Organon Teknika Corp.1997-12-02
QUANTA LITE CMV IGG ELISA (K971335)Inova Diagnostics, Inc.1997-12-01
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973479)Oxoid , Ltd.1997-12-01
ELVIS HSV ID/TYPING TEST SYSTEM (K971662)Diagnostic Hybrids, Inc.1997-11-18
BACT/ALERT CULTURE BOTTLES (K973305)Organon Teknika Corp.1997-11-17
PASCO MIC AND MIC/ID PANELS (K973317)Pasco Laboratories, Inc.1997-11-14
SERODIA TP-PA (K971502)Scimedx Tekfile Services1997-11-13
PASCO MIC AND MIC/ID PANELS (K973695)Pasco Laboratories, Inc.1997-11-05
SERAQUEST VZV IGG (K972295)Quest Intl., Inc.1997-11-05
MUMPS IGG ELISA TESTY (K971857)Gull Laboratories, Inc.1997-11-04
THE MERETEK UBT BREATH TEST FOR H.PYLORI (K972352)Meretek Diagnostics, Inc.1997-10-29
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K971989)Bayer Corp.1997-10-22
SERAQUEST TOXOPLASMA IGM (K971672)Quest Intl., Inc.1997-10-21
QUIX RAPID E. COLI O157 STRIP TEST (K972156)Guardian Scientific, Corp.1997-10-16
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972799)Dade Microscan, Inc.1997-10-10
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973488)Oxoid , Ltd.1997-10-10
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973489)Oxoid , Ltd.1997-10-10
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (K972726)Medical Packaging Corp.1997-10-08
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973487)Oxoid , Ltd.1997-10-06
VIDAS ROTAVIRUS (RTV) ASSAY (K972895)Biomerieux Vitek, Inc.1997-10-03
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES (K971494)Zymetx, Inc.1997-09-10
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN (K972688)Dade Microscan, Inc.1997-09-08
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030)Oxoid , Ltd.1997-09-08
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972524)Dade Intl., Inc.1997-09-08
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN (K972359)Remel, L.P.1997-08-28
VISTA ANTIGEN SALMONELLA O GROUP C (K972388)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP A (K972387)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H B (K972391)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H D (K972389)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H A (K972392)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H C (K972390)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN BRUCELLA ABORTUS (K972394)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP B (K972386)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP D (K972395)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN BRUCELLA MELITENSIS (K972396)Lee Laboratories, Inc.1997-08-25
ACCURUN 146 CMV IGM POSITIVE CONTROL (K972884)Boston Biomedica, Inc.1997-08-22
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971638)Oxoid , Ltd.1997-08-20
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (K972449)Copan Italia Spa1997-08-20
IMMUNOCARD STAT! ROTAVIRUS (K971585)Meridian Diagnostics, Inc.1997-08-20
PASCO MIC AND MIC/ID PANELS (K972567)Pasco Laboratories, Inc.1997-08-20
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (K972448)Copan Italia Spa1997-08-20
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