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Microbiology

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

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RecordFirmDate
LINEZOLID, 30UG, BBL SENSI-DISC (K002165)Dickinson, and Co.2000-09-05
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 (K002453)Beckman Coulter, Inc.2000-08-31
CHROMOSTREAK (K000718)Novamed , Ltd.2000-08-24
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM (K001875)Diamedix Corp.2000-08-21
PASCO MIC AND MIC/ID PANELS (K001953)Pasco Laboratories, Inc.2000-08-10
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (K001887)Pasco Laboratories, Inc.2000-08-09
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (K001767)Diamedix Corp.2000-08-07
ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (K001547)Ab Biodisk2000-08-07
PASCO MIC AND MIC/ID PANELS (K001721)Pasco Laboratories, Inc.2000-08-04
HARDY DISK CLARITHROMYCIN, 15MCG (K001728)Hardy Diagnostics2000-07-27
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) (K001558)Trek Diagnostic Systems, Inc.2000-07-24
PASCO MIC AND MIC/ID PANELS (K001612)Pasco Laboratories, Inc.2000-07-18
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K001573)Trek Diagnostic Systems, Inc.2000-07-18
PASCO MIC AND MIC/ID PANELS (K001516)Pasco Laboratories, Inc.2000-07-12
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM (K001707)Diamedix Corp.2000-07-07
BD DIRECTIGEN FLU A+B (K001364)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-06-28
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (K000687)Beacon Biologicals, Inc.2000-06-12
HARDYDISK CINOXACIN, 100 MCG (K001487)Hardy Diagnostics2000-06-07
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) (K001036)Trek Diagnostic Systems, Inc.2000-06-06
HARDYDISK CEFOPERAZONE, 75 MCG (K001489)Hardy Diagnostics2000-06-01
HARDYDISK CEFONICID, 30 MCG (K001490)Hardy Diagnostics2000-06-01
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG (K000463)Diagnostic Products Corp.2000-06-01
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) (K001035)Trek Diagnostic Systems, Inc.2000-05-23
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 (K993319)bioMerieux, Inc.2000-05-22
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000930)Oxoid , Ltd.2000-05-22
ETEST GATIFLOXACIN (K000596)Ab Biodisk2000-05-22
ETEST MOXIFLOXACIN (K000298)Ab Biodisk2000-05-18
BVBLUE (K993732)Gryphus Diagnostics, LLC2000-05-15
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K000928)Oxoid , Ltd.2000-05-15
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (K000762)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-04-25
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G (K000238)Mrl Diagnostics2000-04-14
HARDYDISK, CEPHALOTHIN 30MCG (K000526)Hardy Diagnostics2000-04-13
GATIFLOXACIN, 5 UG, BBL SENSI-DISC (K000829)Bd Becton Dickinson Vacutainer Systems Preanalytic2000-04-13
HARDYDISK, AMPICILLIN, 10MCG (K000268)Hardy Diagnostics2000-04-07
HARDYDISK CEFTRIAXONE 30MCG (K000440)Hardy Diagnostics2000-04-07
HARDYDISK OFLOXACIN 5MCG (K000525)Hardy Diagnostics2000-04-07
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG (K000261)Hardy Diagnostics2000-04-07
HARDYDISK, VANCOMYCIN 30MCG (K000509)Hardy Diagnostics2000-04-07
HARDYDISK, CEFOTAXIME 30MCG (K000524)Hardy Diagnostics2000-04-07
HARDYDISK, NITROFURANTOIN (K000272)Hardy Diagnostics2000-04-07
HARDYDISK, SULFA/TRIMETH (K000271)Hardy Diagnostics2000-04-07
HARDYDISK, CEFOXITIN, 30MCG (K000305)Hardy Diagnostics2000-03-31
HARDYDISK, TETRACYCLINE 30MCG (K000304)Hardy Diagnostics2000-03-29
HARDY DISK, PENICILLIN, 10 UNITS (K000302)Hardy Diagnostics2000-03-24
HARDYDISK, CIPROFLOXACIN, 5MCG (K000258)Hardy Diagnostics2000-03-21
HARDYDISK, KANAMYCIN, 30MCG (K000203)Hardy Diagnostics2000-03-21
HARDYDISK, CEFTAZIDIME, 30MCG (K000259)Hardy Diagnostics2000-03-21
SAS STREP A TEST (K993456)Sa Scientific, Inc.2000-03-07
BACT/ALERT MB CULTURE BOTTLE (K000378)Organon Teknika Corp.2000-03-02
HARDYDISK, CARBENICILLIN, 100MCG (K000181)Hardy Diagnostics2000-03-02
HARDYDISK TICARILLIN 75MCG (K000175)Hardy Diagnostics2000-03-02
HARDYDISK, NALIDIXIC ACID, 30MCG (K000130)Hardy Diagnostics2000-02-29
HARDYDISK, STREPTOMYCIN 10MCG (K000201)Hardy Diagnostics2000-02-29
HARDYDISK TOBRAMYCIN, 10MCG (K000182)Hardy Diagnostics2000-02-29
HYBRID CAPTURE II CT/GC TEST (K981567)Digene Corp.2000-02-29
DRYSPOT E.COLI 0157 KIT (K993401)Oxoid , Ltd.2000-02-28
HARDYDISK, PIPERACILLIN, 100MCG (K000183)Hardy Diagnostics2000-02-28
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316)Meretek2000-02-24
SYNTHETIC VDRL ANTIGEN (K993633)Centers for Disease Control and Prevention2000-02-23
HARDYDISK, CEFAZOLIN, 30MCG (K000128)Hardy Diagnostics2000-02-18
MICROSTREP PLUS PANEL, LEVOFLOXACIN (K983943)Dade Microscan, Inc.2000-02-18
HARDYDISK CEFAMANDOLE, 30MCG (K000022)Hardy Diagnostics2000-02-17
HARDYDISK OXACILLIN, 1MCG (K994134)Hardy Diagnostics2000-02-17
HARDYDISK NORFLOXACIN, 10MCG (K994150)Hardy Diagnostics2000-02-16
HARDYDISK ERYTHROMYCIN, 15MCG (K994135)Hardy Diagnostics2000-02-16
HARDYDISK MEZLOCILLIN 75MCG (K994212)Hardy Diagnostics2000-02-15
HARDYDISK GENTAMICIN, 10MCG (K994091)Hardy Diagnostics2000-02-11
HARDYDISK CEFIXIME, 5MCG (K994129)Hardy Diagnostics2000-02-11
HARDYDISK CHLORAMPHENICOL, 30MCG (K994089)Hardy Diagnostics2000-02-11
COPALIS RUBELLA IGM (K993291)DiaSorin, Inc.2000-02-10
BACT/ALERT SV (K994343)Organon Teknika Corp.2000-02-10
YEASTEST (K993554)Diagnostic Markers, Inc.2000-02-10
HSV-1 ELISA IGG, MODEL EL0910G (K993754)Mrl Diagnostics2000-02-09
HARDYDISK CEFACLOR 30MCG (K994046)Hardy Diagnostics2000-02-01
HSV-2 ELISA IGG, MODEL EL0920G (K993724)Mrl Diagnostics2000-02-01
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT (K994004)Inova Diagnostics, Inc.2000-01-27
HARDYDISK IMIPENEM, 10MCG (K994132)Hardy Diagnostics2000-01-18
OSOM ULTRA STREP A TEST, MODEL 147 (K992658)Wyntek Diagnostics, Inc.2000-01-18
HARDY DISK AMPICILLIN/SULBACTAM (K994067)Hardy Diagnostics2000-01-14
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN (K993679)Dade Microscan, Inc.2000-01-14
MICROSTREP PLUS PANEL, VANCOMYCIN (K983953)Dade Microscan, Inc.2000-01-14
HARDYDISK AZTREONAM, 30MCG (K994063)Hardy Diagnostics2000-01-14
HARDYDISK DOXYCYCLINE, 30MCG (K994051)Hardy Diagnostics2000-01-10
HARDYDISK AMIKACIN 30MCG (K993993)Hardy Diagnostics1999-12-27
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587)Stellar Bio Systems, Inc.1999-12-22
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (K991074)Intracel Corp.1999-12-21
UNI-GOLD H. PYLORI (K991697)Trinity Biotech, Plc1999-12-21
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K (K993812)Hardy Diagnostics1999-12-21
HARDYDISK AZITHROMYCIN 15MCG (K993994)Hardy Diagnostics1999-12-21
E. HISTOLYTICA II (K994101)Techlab, Inc.1999-12-21
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST (K993048)Roche Diagnostics Corp.1999-12-20
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY (K992552)DiaSorin, Inc.1999-12-16
INTRAY GC (K993033)Biomed Diagnostics, Inc.1999-12-16
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
BACT/ALERT SA (K993423)Organon Teknika Corp.1999-12-15
BACT/ALERT SN (K993421)Organon Teknika Corp.1999-12-14
BACT/ALERT MP PROCESS BOTTLE (K993576)Organon Teknika Corp.1999-12-14
PREMIER TOXINS A&B, MODEL 616096 (K993914)Meridian Diagnostics, Inc.1999-12-10
MICROSTREP PLUS PANEL (K983746)Dade Microscan, Inc.1999-12-09
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K993102)Dade Microscan, Inc.1999-12-02
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