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Microbiology

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

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RecordFirmDate
LYME DISEASE IFA (IGM) (K883767)Hillcrest Biologicals1989-03-15
VISUWELL REAGIN TEST 960 TEST KIT (K885298)Allelix Diagnostics, Inc.1989-03-15
GIARDIA STOOL ANTIGEN TEST KIT (K890003)Lmd Laboratories1989-03-14
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY (K884047)Disease Detection International, Inc.1989-03-14
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089)Gen-Probe, Inc.1989-03-13
VIRGO HSV-2 IGG ELISA (K883281)Electro-Nucleonics, Inc.1989-03-10
VIRGO HSV-1 IGG ELISA (K883282)Electro-Nucleonics, Inc.1989-03-10
VIRGO(R) VZV-IGG ELISA (K883427)Electro-Nucleonics, Inc.1989-03-10
DENTOCULT SM-STRIP MUTANS (K890199)Orion Corp.1989-03-02
LYME ELISA TEST SYSTEM (K885317)Zeus Scientific, Inc.1989-03-02
PHADEBACT SHIGELLA TEST (K880752)Pharmacia, Inc.1989-02-17
JAMES REAGENT (K890625)Dms Products, Inc.1989-02-17
BION DIRECT IDENTIFICATION CONTROL SLIDE (K890616)Bion Ent., Ltd.1989-02-17
PRO DISCS (K882630)Carr-Scarborough Microbiologicals, Inc.1989-02-16
KODAK SURECELL HERPES (HSV) TEST KIT (K884680)Eastman Kodak Company1989-02-16
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (K885310)Whittaker Bioproducts, Inc.1989-02-16
ALN DISCS (K882636)Carr-Scarborough Microbiologicals, Inc.1989-02-16
WELLCOLEX COLOUR SALMONELLA TEST ZL 50 (K890146)Wellcome Diagnostics1989-02-16
VIRGO (R) CMV-IGG ELISA (K883102)Electro-Nucleonics, Inc.1989-02-08
DIFCO DIRECTOR INOCULATION SYSTEM (K890339)Difco Laboratories, Inc.1989-02-07
BACTIGEN(R) N. MENINGITIDIS (K885004)Armkel, LLC1989-02-07
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (K890154)Labsystems, Inc.1989-02-07
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST (K883937)Ortho Diagnostic Systems, Inc.1989-02-07
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST (K885003)Armkel, LLC1989-02-07
BACTIGEN(R) H. INFLUENZAE TYPE B (K884967)Armkel, LLC1989-02-07
BACTIGEN(R) S. PNEUMONIAE (K884966)Armkel, LLC1989-02-07
BACTIGEN(R) MENINGITIDIS PANEL (K884965)Armkel, LLC1989-02-07
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (K890091)Labsystems, Inc.1989-02-03
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (K883776)Btc Corp.1989-02-03
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (K884026)Oxoid U.S.A., Inc.1989-02-03
PF TEST (K884513)Medi-Tech, Inc.1989-02-03
IMMUNODOT TORCH TEST RUBELLA (K884898)General Biometrics, Inc.1989-02-03
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY (K884617)Ortho Diagnostic Systems, Inc.1989-02-02
IMMUNODOT RUBELLA TEST (K885082)General Biometrics, Inc.1989-02-02
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM (K882999)Organon Teknika Corp.1989-01-31
QUIK-DOT ANTISTREPTOLYSIN-O (K890025)Ampcor, Inc.1989-01-31
ROTACUBE (K884017)Difco Laboratories, Inc.1989-01-24
EBV-VCA ANTIBODY (IGG) (K884591)Hillcrest Biologicals1989-01-24
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA (K883720)Lmd Laboratories1989-01-24
LYME FAST TEST (K883544)3M Company1989-01-13
FITC MURINE MONOCLONAL ANTI-RSV IGG (K884516)Whittaker Bioproducts, Inc.1989-01-13
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST (K883935)Ortho Diagnostic Systems, Inc.1989-01-04
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST (K883940)Ortho Diagnostic Systems, Inc.1989-01-04
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST (K883939)Ortho Diagnostic Systems, Inc.1988-12-22
GROUP A STREP, BETA-STREP (K884750)Ampcor, Inc.1988-12-22
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST (K883938)Ortho Diagnostic Systems, Inc.1988-12-22
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION (K885006)Abbott Laboratories1988-12-16
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST (K882440)Zeus Scientific, Inc.1988-12-15
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES (K882447)Zeus Scientific, Inc.1988-12-15
WASHER 500 MICROELISA SYSTEM (K884695)Organon Teknika Corp.1988-12-13
LYME DISEASE IFA (IGG) (K883487)Hillcrest Biologicals1988-12-13
MODIFIED IDEIA CHLAMYDIA TEST (K880799)Boots-Celltech Diagnostics, Inc.1988-12-08
RUBEOLA TEST (K884004)Gull Laboratories, Inc.1988-12-05
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (K884761)Difco Laboratories, Inc.1988-12-05
INDIRECT FLUORESCENT ASSAY FOR (HCMV) (K882835)Stellar Bio Systems, Inc.1988-12-05
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125)Bio-Tek Instruments, Inc.1988-12-02
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED (K884517)Kallestad Diag, A Div. of Erbamont, Inc.1988-11-30
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION (K884191)Baxter Diagnostics, Inc.1988-11-22
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (K884194)Baxter Diagnostics, Inc.1988-11-22
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (K884193)Baxter Diagnostics, Inc.1988-11-22
MODIFICATION MIC/API UNISCEPT(R) (K884509)Analytical Products, Inc.1988-11-22
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (K884192)Baxter Diagnostics, Inc.1988-11-22
MODIFICATION MICRO-MIC (K884510)Analytical Products, Inc.1988-11-22
KODAK SURECELL CHLAMYDIA TEST KIT (K882923)Eastman Kodak Company1988-11-10
NOVAPATH SPECIMEN COLLECTION KIT (K884342)Bio-Rad1988-11-03
FIAGEN RUBELLA IGG (K883182)Cyberfluor, Inc.1988-10-31
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT (K882629)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-31
SCEPTORPETTE SYSTEM (K883907)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-27
STREPSLIDE (K882811)Ncs Diagnostics, Inc.1988-10-25
RUBELLA IGM MICROASSAY (K883778)Diamedix Corp.1988-10-25
FDL ELISA FOR CHLAMYDIA (K883266)Fairleigh Dickinson Laboratories, Inc.1988-10-25
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208)Oxoid U.S.A., Inc.1988-10-25
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM (K883083)Medical Diagnostic Technologies, Inc.1988-10-25
CDT CYTOTOXI TEST (K883560)Advanced Clinical Diagnostics1988-10-25
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL (K883798)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
X-ACT LDC/IND (K883996)Pro-Lab, Inc.1988-10-12
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL (K883800)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
QUIDEL GROUP A STREP TEST (K883999)Quidel Corp.1988-10-12
X-ACT UREA/TDA (K883995)Pro-Lab, Inc.1988-10-12
B. FRAGTEX (K881380)American Biomedical Products, Inc.1988-10-06
HISTO-CHECK FUNGAL CONTROL SLIDES (K883570)Val Tech Diagnostics, Inc.1988-10-06
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (K883352)Whittaker Bioproducts, Inc.1988-10-06
HISTO-CHECK LEGIONELLA CONTROL SLIDES (K883567)Val Tech Diagnostics, Inc.1988-10-06
HISTO-CHECK GRAM NEGATIVE SLIDES (K883569)Val Tech Diagnostics, Inc.1988-10-06
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 (K882475)Amersham Corp.1988-10-06
HISTO-CHECK PARASITIC CONTROL SLIDES (K883571)Val Tech Diagnostics, Inc.1988-10-06
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST (K883936)Ortho Diagnostic Systems, Inc.1988-10-06
HISTO-CHECK ACID FAST SLIDES (K883568)Val Tech Diagnostics, Inc.1988-10-06
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST (K882199)Auspharm Intl. , Ltd.1988-10-06
ON THE SPOT CANDIDASURE (K883118)Medi-Tech, Inc.1988-09-30
URISCREEN (K882211)Diatech Diagnostica , Ltd.1988-09-30
TOXOPLASMA GONDII IGG ELISA KIT (K875258)De Ferris Laboratories, Inc.1988-09-30
HERPES VIRUS CONTROL SLIDES (K883684)Val Tech Diagnostics, Inc.1988-09-28
IMMUNO/FEBRILE ANTIGENS (K883685)Immunostics Co., Inc.1988-09-28
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 (K883551)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-27
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 (K883554)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 (K883548)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 (K883555)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STREPTOCOCCUS MIC PANEL #80322 (K883549)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
SCEPTOR STAPHYLOCOCCUS MIC #80324 (K883550)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-26
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