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Microbiology

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

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RecordFirmDate
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 (K883552)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 (K883553)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
VITEK GRAM-NEGATIVE IDENTIFICATION CARD (K883558)Vitek Systems, Inc.1988-09-16
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL (K882477)Pasco Laboratories, Inc.1988-09-08
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST (K883385)Los Alamos Diagnostics1988-09-07
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS (K883076)Baxter Healthcare Corp1988-09-07
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (K883394)Baxter Healthcare Corp1988-09-07
PHADEBACT ETEC-LT TEST (K874288)Pharmacia, Inc.1988-09-02
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) (K880884)Immuno Concepts, Inc.1988-08-30
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (K882687)Gull Laboratories, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (K880883)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) (K880886)Immuno Concepts, Inc.1988-08-30
DU PONT EBNA-IGG ANTIBODY ELISA KIT (K875203)E.I. Dupont DE Nemours & Co., Inc.1988-08-30
PHARMACIA CHLAMYDIA EIA (K882676)Pharmacia, Inc.1988-08-29
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN (K882909)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-29
XACT NEISSERIA (K880511)Austin Biological Laboratories1988-08-25
HISTO-CHECK SLIDES (K883208)Val Tech Diagnostics, Inc.1988-08-25
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529)Diagnostic Hybrids, Inc.1988-08-25
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (K883333)Immuno-Mycologics, Inc.1988-08-25
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN (K882911)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM (K882912)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC (K882910)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-17
FASTIDIOUS INOCULUM BROTH (K883075)Baxter Healthcare Corp1988-08-15
IDS RAPID ANA SYSTEM (K882960)Innovative Diagnostic Systems, Inc.1988-08-12
MERIFLUOR(TM) PNEUMOCYSTIS (K881608)Meridian Diagnostics, Inc.1988-08-04
CAPTIA(R) SYPHILIS-G (K881425)Mercia Diagnostics , Ltd.1988-08-04
WELLCOZYME HSV WZO2 (K875311)Wellcome Diagnostics1988-08-03
FITC MURINE MONOCLONAL ANTI-CMV IGG (K882024)Whittaker Bioproducts, Inc.1988-08-03
COLORGENE HSV DNA HYBRIDIZATION TEST (K880604)Enzo Biochem, Inc.1988-08-03
FIAX TEST KIT FOR EB-VCA-G ANTIBODY (K882023)Whittaker Bioproducts, Inc.1988-08-03
CAPTIA TOXO-G (K880918)Mercia Diagnostics , Ltd.1988-08-01
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (K881932)Ortho Diagnostic Systems, Inc.1988-08-01
ABBOTT TESTPACK CHLAMYDIA (K880783)Abbott Laboratories1988-07-25
SOC SLIDE CULTURE SYSTEM (K882371)The Cancer Center AT Wadley Institutes1988-07-18
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL (K882299)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-18
DIVERSI-KIT (K882485)Intl. Cancer Screening Laboratories, Inc.1988-07-18
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR (K881716)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-14
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL (K882535)Abbott Laboratories1988-07-14
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) (K882301)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (K882534)Abbott Laboratories1988-07-12
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) (K882300)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-12
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (K882580)Precision Dynamics Corp.1988-07-08
DU PONT VCA-IGM ANTIBODY ELISA KIT (K875204)E.I. Dupont DE Nemours & Co., Inc.1988-07-08
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (K881894)Cambridge Bioscience Corp.1988-07-08
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN (K881846)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-08
ACCU-CULSHURE TM (K882637)Accu-Med Corp.1988-07-06
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS (K882029)Pasco Laboratories, Inc.1988-07-06
G-MARK (K880076)Bainbridge Laboratories, Inc.1988-07-01
MINIFUGE, MODEL 70 (K882149)Utah Bioresearch, Inc.1988-07-01
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495)Lakewood Biochemical Co., Inc.1988-07-01
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (K882351)Lakewood Biochemical Co., Inc.1988-06-28
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463)Lakewood Biochemical Co., Inc.1988-06-22
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL (K882277)Abbott Laboratories1988-06-22
B. CAT CONFIRM (K880694)Scott Laboratories, Inc.1988-06-16
VITEK YEAST BIOCHEMICAL CARD (K881925)Vitek Systems, Inc.1988-06-16
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670)Molecular Biosystems, Inc.1988-06-08
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (K881617)Granbio, Inc.1988-06-07
BION HSV1-G OR HSV2-G TEST SYSTEM (K881261)Bion Ent., Ltd.1988-06-07
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (K882182)Lakewood Biochemical Co., Inc.1988-06-06
BION CMV-G TEST SYSTEM (K880679)Bion Ent., Ltd.1988-06-03
HYGEIA GC TEST (K881064)Hygeia Sciences1988-06-02
DIAMOND'S MEDIUM MODIFIED (K881995)Remel Co.1988-06-02
ATS NAC-PAC SET (K881949)Alpha-Tec Systems, Inc.1988-05-25
THE DDI SERODOT HERPES IGG TEST KIT (K875366)Disease Detection International, Inc.1988-05-23
CHLAMYDIAZYME(TM) (K880469)Abbott Laboratories1988-05-23
EBNA ANTIBODY (K875170)Hillcrest Biologicals1988-05-23
STANBIO SYPHILIS RPR TEST, NO. 1170 (K880144)Stanbio Laboratory1988-05-23
MODIFIED IDS RAPID NH SYSTEM (K881501)Innovative Diagnostic Systems, Inc.1988-05-18
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG (K881180)Whittaker Bioproducts, Inc.1988-05-13
TRICHOMATE(R) SUPER (K875138)Mercia Diagnostics , Ltd.1988-05-13
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (K873565)Molecular Biosystems, Inc.1988-05-13
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT (K875361)Disease Detection International, Inc.1988-05-13
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG (K880996)Whittaker Bioproducts, Inc.1988-05-13
SENSITITRE STABILITY PLATES (K880641)Sensititre , Ltd.1988-05-13
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. (K872541)Ortho Diagnostic Systems, Inc.1988-05-13
ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (K881879)Alpha-Tec Systems, Inc.1988-05-13
ABBOTT CMV-M EIA KIT (K872881)Abbott Laboratories1988-05-13
DETECTADOT SYSTEM 2000 CMV IGG TEST (K875159)Gull Laboratories, Inc.1988-05-06
CATHRA GRAM POSITIVE SCREEN (K874606)Mct Medical, Inc.1988-05-06
ABBOTT TESTPACK RSV (K874127)Abbott Laboratories1988-05-06
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS (K880821)Abbott Laboratories1988-05-06
MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (K880574)Merck, Sharp & Dohme1988-05-04
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM (K881439)Los Alamos Diagnostics1988-04-28
BREWER GEL FOR CAMPYLOBACTER (K881502)Fairleigh Dickinson Laboratories, Inc.1988-04-27
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (K881500)Ortho Diagnostic Systems, Inc.1988-04-27
LYME DISEASE ELISA (K880476)Hillcrest Biologicals1988-04-26
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS (K881277)Gen-Probe, Inc.1988-04-25
CULTURE COLLECTION DEVICE (K881105)Medical Packaging Corp.1988-04-25
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES (K881106)Sigma Diagnostics, Inc.1988-04-21
SPIROCHETES HISTOLOGY CONTROL SLIDES (K881109)Sigma Diagnostics, Inc.1988-04-21
FUNGI HISTOLOGY CONTROL SLIDES (K881112)Sigma Diagnostics, Inc.1988-04-21
MODIFIED PARACON(TM) CONCENTRATION KIT (K881649)Para Scientific Co.1988-04-21
KODAK SURECELL STREP A TEST KIT (K881457)Eastman Kodak Company1988-04-21
SERODOT TOXOPLASMA IGG TEST KIT (K875363)Disease Detection International, Inc.1988-04-21
MICROTRAK CMV CULTURE CONFIRMATION TEST (K880290)Syva Co.1988-04-19
HEMOGLOBIN POWDER (K881566)Acumedia Manufacturers, Inc.1988-04-18
OF BASAL MEDIUM (K881550)Acumedia Manufacturers, Inc.1988-04-18
CASMAN MEDIUM BASE (K881527)Acumedia Manufacturers, Inc.1988-04-18
AMIES TRANSPORT MEDIUM (K881539)Acumedia Manufacturers, Inc.1988-04-18
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