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 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 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 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 Aug 11, 1983
READER MICROELISA SYSTEM
K831641
Organon Teknika Corp.
Chemistry · 80d
Cleared Aug 08, 1983
IMMULON SUBSTRATE REMOVAWELL STRIPS
K832117
Dynatech Corp.
Chemistry · 39d
Cleared Jul 26, 1983
HEATING BLOCK MICROELISA SYSTEM
K831642
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
STRIPREADER MICROELISA SYSTEM
K831643
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
MICROELISA COMP
K831658
Organon Teknika Corp.
Chemistry · 64d
Cleared Jun 08, 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448
R&D Systems, Inc.
Chemistry · 34d
Cleared Jun 02, 1983
DISPOSABLE STERILE FILTER SYSTEM
K831450
Corning Medical & Scientific
Pathology · 28d
Cleared Mar 09, 1983
HANDI-WASH
K823787
Dynatech Corp.
Chemistry · 83d
Cleared Mar 08, 1983
MICRO STIX #011-010-5000 & HOLDER#5100
K823833
Dynatech Corp.
Chemistry · 77d
Cleared Dec 28, 1982
REMOVAWELL PLATE LID
K823557
Dynatech Corp.
Chemistry · 26d
Cleared Nov 16, 1982
MICROFLUOR B PLATE & MICRO FLUOR W PLATE
K822960
Dynatech Corp.
Chemistry · 42d

About Product Code LIB - Regulatory Context