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Microbiology

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

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RecordFirmDate
FERRIC CHLORID REAGENT, 10% (K931413)Hardy Diagnostics1993-05-11
BACTIDROP(TM) MUCAP (K930878)Remel Co.1993-05-11
BILE SPOT REAGENT (K931530)Hardy Diagnostics1993-05-11
DISPENS-O-DISC CEFPODOXIME 10 MCG. (K930946)Difco Laboratories, Inc.1993-04-27
DISPENS-O-DISC CLARITHROMYCIN 15 MG. (K930911)Difco Laboratories, Inc.1993-04-27
VOGUES-PROSKAUER REAGENT A & B (K930720)Hardy Diagnostics1993-04-23
NITRATE REAGENTS A, B AND C (K930717)Hardy Diagnostics1993-04-23
INDOLE SPOT & INDOLE KOVACS REAGENT (K930718)Hardy Diagnostics1993-04-23
PROSPEC T GIARDIA MICROTITER ASSAY (K930451)Alexon, Inc.1993-04-21
BARTELS CYTOMEGALOVIRUS IGG EIA (K922582)Baxter Diagnostics, Inc.1993-04-08
BARTELS CYTOMEGALOVIRUS IGM EIA (K922580)Baxter Diagnostics, Inc.1993-04-08
THREE SPIKE CUP (K922870)Osteo Technology, Inc.1993-04-08
QUIKPAC STREP A TEST (K924007)Syntron Bioresearch, Inc.1993-04-06
ROCHE OXI/FERM II (K923313)Roche Diagnostic Systems, Inc.1993-04-05
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K930055)Alamar Biosciences Laboratory, Inc.1993-04-05
CMV ELISA TEST SYSTEM (K924096)Zeus Scientific, Inc.1993-04-02
DRIED GRAM-NEGATIVE MIC/COMBO PANELS (K926545)Baxter Diagnostics, Inc.1993-03-26
CULTURETTE BRAND TOXIN CD TEST (K925329)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-03-24
TOXOPLASMA IGM IFA TEST SYSTEM (K924882)Zeus Scientific, Inc.1993-03-23
PYLORISCREEN (K925190)New Horizons Diagnostics Co.1993-03-23
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (K925916)Biomerieux Vitek, Inc.1993-03-23
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (K925915)Biomerieux Vitek, Inc.1993-03-23
CODMAN GAAB NEUROENDOSCOPE (K923555)Codman & Shurtleff, Inc.1993-03-23
APEX SPECIMEN BAG (K930313)Apex Medical Technologies, Inc.1993-03-18
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL (K922482)Baxter Diagnostics, Inc.1993-03-12
API 20E/UNISCEPT 20E (K924814)Analytical Products, Inc.1993-03-11
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (K926017)Becton Dickinson Microbiology Systems1993-03-11
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (K926018)Becton Dickinson Microbiology Systems1993-03-11
SENSITITRE SUSCEPTIBILITY PLATES (K923045)Radiometer America, Inc.1993-03-09
BACTEC PEDS PLUS/F (K926304)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-03-04
VIDAS TOXOPLASMA GONDII IGM ASSSAY (K923166)Biomerieux Vitek, Inc.1993-02-25
ADAMS SCIENTIFIC SENSITIVITY DISCS (K925969)Adams Scientific, Inc.1993-02-12
VIDAS CMV IGG ASSAY (K920661)Vitek Systems, Inc.1993-02-12
KALLESTAD RSV MICROPLATE EIA (K924289)Bio-Rad Laboratories, Inc.1993-02-12
INDXTM DIP-S-TICKSTM (K920569)Intercare Diagnostics, Inc.1993-02-09
BAC-T-SCREEN (K924218)Biomerieux Vitek, Inc.1993-02-03
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT (K923463)Techlab, Inc.1993-02-01
PREMIER C. DIFFICILE, MODIFICATION (K926442)Meridian Diagnostics, Inc.1993-01-27
BBL NITRATE A, B REAGENT DROPPERS (K926255)Becton Dickinson Microbiology Systems1993-01-26
BBL NINHYDRIN REAGENT DROPPERS (K926256)Becton Dickinson Microbiology Systems1993-01-26
IMMUNOCARD(TM) C. DIFFICILE (K924979)Meridian Diagnostics, Inc.1993-01-26
BBL PYR REAGENT DROPPERS (K926254)Becton Dickinson Microbiology Systems1993-01-26
CATION ADJUSTED MUELLER HINTON BROTH (K925644)Pasco Laboratories, Inc.1993-01-15
EZ VIEW (K925693)Difco Laboratories, Inc.1993-01-15
DRYSLIDE(TM) INDOLE (K925747)Difco Laboratories, Inc.1993-01-15
CYTOQUANT COMBINED TRANSPORT MEDIA (K924053)Proteins Intl., Inc.1993-01-15
MICROSPORIDIUM CONTROL SLIDE (K924893)Scientific Device Laboratory, Inc.1993-01-15
TOXOGEN (K913467)Biokit USA, Inc.1993-01-11
EBV-VCA IGG ELISA TEST SYSTEM (K924091)Zeus Scientific, Inc.1993-01-11
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (K922801)Light Diagnostics1993-01-06
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (K924006)Baxter Healthcare Corp1992-12-29
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION (K925208)Ortho Diagnostic Systems, Inc.1992-12-28
TRANSYSTEM LIQUID STUART MEDIUM (K924331)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM AMIES WITH CHARCOAL (K924330)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM LIQUID AMIES MEDIUM (K924328)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM AMIES W/O CHARCOAL (K924329)Pro-Lab Diagnostics1992-12-24
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA (K922334)Baxter Diagnostics, Inc.1992-12-15
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA (K922333)Baxter Diagnostics, Inc.1992-12-15
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS (K922458)Baxter Healthcare Corp1992-12-11
CHOLERASCREEN (K922432)New Horizons Diagnostics Co.1992-12-07
ACCUTEX ASO LATEX TEST (K924247)J.S. Medical Assoc.1992-12-07
ARBOVIRUS IGG IFA TEST (K913617)Hillcrest Biologicals1992-12-03
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (K923684)Analytical Products, Inc.1992-12-03
ARBOVIRUS IGM IFA TEST (K913618)Hillcrest Biologicals1992-12-03
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK (K925060)Remel Co.1992-12-03
NEOTHROMITIN(R) (K924395)Behring Diagnostics, Inc.1992-12-01
FILTERMATE UNIVERSAL HARVESTER (K924907)Packard Instrument Co., Inc.1992-12-01
ANTIMICROBIAL SUSCEPTIBILITY TEST (K924500)Alamar Biosciences Laboratory, Inc.1992-11-30
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK (K924846)Remel Co.1992-11-30
CEFPODOXIME 10 MCG, SENSI DISC (K924797)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-11-02
NIZYME TEST KIT (K923566)Remel Co.1992-11-02
REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK (K924765)Remel Co.1992-10-26
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK (K924766)Remel Co.1992-10-26
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K923122)Biomerieux Vitek, Inc.1992-10-26
Q FEVER IGM IFA TEST (K922374)Hillcrest Biologicals1992-10-21
Q FEVER IGG IFA TEST (K913906)Hillcrest Biologicals1992-10-21
FUNGI FLUOR KIT (K923349)Polysciences, Inc.1992-10-20
PREMIER C. DIFFICILE TOXIN A CONTROLS (K924136)Meridian Diagnostics, Inc.1992-10-19
MERITEC C. DIFFICILE CONTROLS (K924062)Meridian Diagnostics, Inc.1992-10-19
RAPID NFT, MODIFICATION (K922768)Biomerieux Vitek, Inc.1992-10-14
API UNISCEPT KB/TYPE 2 AND 3 (K922926)Analytical Products, Inc.1992-10-13
INDOXYL ACETATE DISK (K923700)Remel Co.1992-10-05
HSV-2 IGM ELISA TEST--MODIFICATION (K922759)Gull Laboratories, Inc.1992-10-05
HSV-1 IGM ELISA TEST -- MODIFICATION (K922758)Gull Laboratories, Inc.1992-10-05
PREMIER BLASTOMYCES (K923859)Meridian Diagnostics, Inc.1992-10-05
SALMONELLA O GROUPING ANTISERA SET (K912791)S.M.I. Medical, Inc.1992-10-05
MICRO TRAK XL SYSTEM (K921747)Syva Co.1992-10-01
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA (K922583)Baxter Diagnostics, Inc.1992-09-28
LAP DISK (K923827)Remel Co.1992-09-28
DIASLIDE URINE CULTURING DEVICE (K921045)Savyon Diagnostics , Ltd.1992-09-28
PRECISE STREP A (K923673)Becton Dickinson Advanced Diagnostics1992-09-28
SLIDEX STAPH-KIT (K923212)Biomerieux Vitek, Inc.1992-09-28
AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (K922457)Microprobe Corp.1992-09-25
SYVA MICROTRAK CHLAMYDIA EIA (K920503)Syva Co.1992-09-25
MICROTRAK(R) II CHLAMYDIA EIA ASSAY (K921462)Syva Co.1992-09-25
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (K923133)Microprobe Corp.1992-09-25
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723)Simplicity Diagnostics, Inc.1992-09-18
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA (K922584)Baxter Diagnostics, Inc.1992-09-18
ENOXACIN 10 MCG. SENSI SISC (K923952)Becton Dickinson Microbiology Systems1992-09-18
BARTELS RUBELLA IGG EIA (K922586)Baxter Diagnostics, Inc.1992-09-17
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