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
43 devices
25–43 of 43
Cleared Oct 27, 1983
HCC-MYCOBACTERIA STAIN KIT
K833131
Dr. C.V. Jacob
Microbiology · 44d
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
Cleared Nov 16, 1982
MICROFLUOR B REMOVAWELL STRIPS
K822962
Dynatech Corp.
Chemistry · 42d
Cleared Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292
American Dade
Chemistry · 23d
Cleared Mar 04, 1982
CALI-LOOP
K820345
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
CALI-PIPETTE
K820346
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Jan 28, 1982
MINIWASH II
K813640
Dynatech Corp.
Chemistry · 28d
Cleared Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
K820043
American Dade
Chemistry · 21d
Cleared Sep 08, 1981
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
K812068
Hexcel Medical
Microbiology · 49d