LIB · Class I · 21 CFR 866.2660

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

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

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 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 Nov 20, 1985
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423
Dynatech Laboratories, Inc.
Microbiology · 15d
Cleared Aug 11, 1983
READER MICROELISA SYSTEM
K831641
Organon Teknika Corp.
Chemistry · 80d
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 Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292
American Dade
Chemistry · 23d
Cleared Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
K820043
American Dade
Chemistry · 21d

About Product Code LIB - Regulatory Context