FDA 510(k) Applications for Medical Device Product Code "LIB"
(Device, General Purpose, Microbiology, Diagnostic)

FDA 510(k) Number Applicant Device Name Decision Date
K862112 ABCO DEALERS, INC. MICROSCOPE SLIDES 06/13/1986
K822292 AMERICAN DADE DISPOSABLE DISPENSING-SPREAD PIPETS 08/25/1982
K820043 AMERICAN DADE TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY 01/28/1982
K920416 BEHRING DIAGNOSTICS, INC. SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB 04/08/1992
K820345 CARR-SCARBOROUGH MICROBIOLOGICALS, INC. CALI-LOOP 03/04/1982
K820346 CARR-SCARBOROUGH MICROBIOLOGICALS, INC. CALI-PIPETTE 03/04/1982
K871559 CORNING COSTAR CORP. CELL LIFTER 05/15/1987
K872273 CORNING MEDICAL & SCIENTIFIC CORNING "EASY WASH" ELISA PLATES 07/07/1987
K863789 CORNING MEDICAL & SCIENTIFIC CORNING ELISA PLATES 10/03/1986
K831450 CORNING MEDICAL & SCIENTIFIC DISPOSABLE STERILE FILTER SYSTEM 06/02/1983
K833131 DR. C.V. JACOB HCC-MYCOBACTERIA STAIN KIT 10/27/1983
K854604 DYNATECH CORP. AUTO MASH 12/06/1985
K823787 DYNATECH CORP. HANDI-WASH 03/09/1983
K832117 DYNATECH CORP. IMMULON SUBSTRATE REMOVAWELL STRIPS 08/08/1983
K823833 DYNATECH CORP. MICRO STIX #011-010-5000 & HOLDER#5100 03/08/1983
K822960 DYNATECH CORP. MICROFLUOR B PLATE & MICRO FLUOR W PLATE 11/16/1982
K822962 DYNATECH CORP. MICROFLUOR B REMOVAWELL STRIPS 11/16/1982
K854602 DYNATECH CORP. MINI MASH 2000 12/06/1985
K813640 DYNATECH CORP. MINIWASH II 01/28/1982
K854603 DYNATECH CORP. MULTI MASH 2000 12/06/1985
K823557 DYNATECH CORP. REMOVAWELL PLATE LID 12/28/1982
K854423 DYNATECH LABORATORIES, INC. IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES 11/20/1985
K842052 GELMAN SCIENCES, INC. GIARDIA GUARD 09/11/1984
K912558 GULL LABORATORIES, INC. GULL ELISAWARE 09/16/1991
K812068 HEXCEL MEDICAL PROPOSED CONTROLS FOR DOSIMETRIC RELEASE 09/08/1981
K864249 MDS LABORATORIES, INC. NORMAL SALINE STERILE 03/31/1987
K853745 MICROTECH MEDICAL SYSTEMS, INC. MIC-CONCEPT VIEWBOX 09/19/1985
K850725 MICROTECH MEDICAL SYSTEMS, INC. QUADRA TITER MICRO PLATES 04/30/1985
K831642 ORGANON TEKNIKA CORP. HEATING BLOCK MICROELISA SYSTEM 07/26/1983
K831658 ORGANON TEKNIKA CORP. MICROELISA COMP 07/26/1983
K831641 ORGANON TEKNIKA CORP. READER MICROELISA SYSTEM 08/11/1983
K831643 ORGANON TEKNIKA CORP. STRIPREADER MICROELISA SYSTEM 07/26/1983
K023677 OSMETECH OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) 01/29/2003
K841390 PLASTIC INJECTORS, INC. CODE-A-WELL 05/02/1984
K841632 PLASTIC INJECTORS, INC. CODE-A-WELL SERIES 200 PLATE 05/25/1984
K841937 PLASTIC INJECTORS, INC. CODE-A-WELL SERIES 300 PLATE 05/22/1984
K842057 POLYMER TECHNOLOGY CORP. MACLEAN-FOGG, DISPOS-INOCULA-LOOPS 06/07/1984
K844473 PORTABLE MEDICAL LABORATORIES, INC. HAND-HELD SLIDE READER 01/04/1985
K844476 PORTABLE MEDICAL LABORATORIES, INC. PORTABLE DIAGNOSTIC LABORATORY 03/13/1985
K844442 PORTABLE MEDICAL LABORATORIES, INC. RAPID DIAGNOSTIC KIT 02/01/1985
K831448 R & D SYSTEMS, INC. SPIA SYS FOR SOLID PHASE IMMUNOASSAYS 06/08/1983
K853285 SCIENTIFIC SALES INTL., INC. MYWASHER 5 10/04/1985
K843483 ZIMMAR CONSULTING LTD. PHARMA-PLAST PETRI DISH 09/21/1984


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