Bio-Tek Instruments, Inc. - FDA 510(k) Cleared Devices
37
Total
35
Cleared
0
Denied
15 devices
Cleared
Oct 25, 1995
ELX808 AUTOMATED MICROPLATE READERS
Chemistry
77d
Cleared
Oct 19, 1995
ELX800UV
Chemistry
80d
Cleared
Mar 21, 1995
ELX800 AND EL800 AUTOMATED MICROPLATE READERS
Chemistry
69d
Cleared
Feb 06, 1995
CERES 900C & CERES UV900C
Chemistry
230d
Cleared
Oct 29, 1993
ELS 1000
Chemistry
101d
Cleared
Aug 19, 1993
OMNI
Chemistry
286d
Cleared
Nov 27, 1991
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
Chemistry
26d
Cleared
May 23, 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
Chemistry
51d
Cleared
Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
Chemistry
34d
Cleared
Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
Chemistry
34d
Cleared
Feb 27, 1990
AUTOREADER CALIBRATION TEST PLATE
Chemistry
20d
Cleared
Mar 16, 1989
EIA READER MODEL EL301
Chemistry
23d
Cleared
Jan 03, 1989
AUTOMATED EIA READER MODEL EL311
Chemistry
95d
Cleared
Dec 02, 1988
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
Chemistry
63d
Cleared
Jun 11, 1984
AUTOMATED EIA MICROPLATE READER EL310
Chemistry
18d