LIB · Class I · 21 CFR 866.2660

FDA Product Code LIB: Device, General Purpose, Microbiology, Diagnostic

Leading manufacturers include Dynatech Corp., Organon Teknika Corp. and Corning Medical & Scientific.

43
Total
43
Cleared
46d
Avg days
1981
Since

FDA 510(k) Cleared Device, General Purpose, Microbiology, Diagnostic Devices (Product Code LIB)

43 devices
1–24 of 43
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677
Osmetech
Microbiology · 89d
Cleared Apr 08, 1992
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416
Behring Diagnostics, Inc.
Microbiology · 68d
Cleared Sep 16, 1991
GULL ELISAWARE
K912558
Gull Laboratories, Inc.
Microbiology · 97d
Cleared Jul 07, 1987
CORNING EASY WASH ELISA PLATES
K872273
Corning Medical & Scientific
Chemistry · 22d
Cleared May 15, 1987
CELL LIFTER
K871559
Corning Costar Corp.
Microbiology · 23d
Cleared Mar 31, 1987
NORMAL SALINE STERILE
K864249
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Oct 03, 1986
CORNING ELISA PLATES
K863789
Corning Medical & Scientific
Chemistry · 7d
Cleared Jun 13, 1986
MICROSCOPE SLIDES
K862112
Abco Dealers, Inc.
Microbiology · 10d
Cleared Dec 06, 1985
MINI MASH 2000
K854602
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
MULTI MASH 2000
K854603
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
AUTO MASH
K854604
Dynatech Corp.
Microbiology · 18d
Cleared Nov 20, 1985
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423
Dynatech Laboratories, Inc.
Microbiology · 15d
Cleared Oct 04, 1985
MYWASHER 5
K853285
Scientific Sales Intl., Inc.
Microbiology · 60d
Cleared Sep 19, 1985
MIC-CONCEPT VIEWBOX
K853745
Microtech Medical Systems, Inc.
Microbiology · 10d
Cleared Apr 30, 1985
QUADRA TITER MICRO PLATES
K850725
Microtech Medical Systems, Inc.
Microbiology · 67d
Cleared Mar 13, 1985
PORTABLE DIAGNOSTIC LABORATORY
K844476
Portable Medical Laboratories, Inc.
Chemistry · 114d
Cleared Feb 01, 1985
RAPID DIAGNOSTIC KIT
K844442
Portable Medical Laboratories, Inc.
Microbiology · 77d
Cleared Jan 04, 1985
HAND-HELD SLIDE READER
K844473
Portable Medical Laboratories, Inc.
Microbiology · 46d
Cleared Sep 21, 1984
PHARMA-PLAST PETRI DISH
K843483
Zimmar Consulting , Ltd.
Microbiology · 15d
Cleared Sep 11, 1984
GIARDIA GUARD
K842052
Gelman Sciences, Inc.
Microbiology · 112d
Cleared Jun 07, 1984
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS
K842057
Polymer Technology Corp.
Microbiology · 16d
Cleared May 25, 1984
CODE-A-WELL SERIES 200 PLATE
K841632
Plastic Injectors, Inc.
Microbiology · 35d
Cleared May 22, 1984
CODE-A-WELL SERIES 300 PLATE
K841937
Plastic Injectors, Inc.
Microbiology · 11d
Cleared May 02, 1984
CODE-A-WELL
K841390
Plastic Injectors, Inc.
Microbiology · 29d

About Product Code LIB - Regulatory Context