Medical Device Manufacturer · US , East Walpole , MA

Ciba Corning Diagnostics Corp. - FDA 510(k) Cleared Devices

125 submissions · 125 cleared · Since 1986
125
Total
125
Cleared
0
Denied
100 devices
76-100 of 100
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · CDP
Chemistry · 56d
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749 · JJE
Chemistry · 34d
Cleared Sep 08, 1987
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
K872302 · JJE
Chemistry · 85d
Cleared Aug 25, 1987
CIBA CORNING 288 PH/BLOOD GAS SYSTEM
K872888 · JQY
Chemistry · 33d
Cleared Aug 05, 1987
AMYLASE TEST KIT
K872023 · JFJ
Chemistry · 71d
Cleared Jul 31, 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · JGS
Chemistry · 21d
Cleared Jul 21, 1987
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · CDX
Chemistry · 35d
Cleared May 28, 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · JGS
Chemistry · 73d
Cleared May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987 · JHX
Chemistry · 76d
Cleared May 26, 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · JJQ
Chemistry · 12d
Cleared May 14, 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · CDX
Chemistry · 65d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833 · JJE
Chemistry · 29d
Cleared Mar 06, 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · CHL
Chemistry · 73d
Cleared Feb 25, 1987
710 PLUS
K864557 · JQP
Chemistry · 98d
Cleared Jan 14, 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · JJS
Chemistry · 9d
Cleared Dec 16, 1986
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
K864132 · KHQ
Chemistry · 56d
Cleared Oct 14, 1986
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · KLI
Chemistry · 125d
Cleared Oct 07, 1986
ABNORMAL SPINAL FLUID CONTROL
K863745 · JJY
Chemistry · 13d
Cleared Sep 08, 1986
CIBA CORNING MAGIC LITE ANALYZER
K862235 · JJE
Chemistry · 89d
Cleared Aug 29, 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · JLW
Chemistry · 65d
Cleared Jul 02, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · JJY
Chemistry · 106d
Cleared Jun 27, 1986
TOTAL BILIRUBIN TEST KIT
K861998 · CIG
Chemistry · 35d
Cleared Apr 07, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · JJY
Chemistry · 18d
Cleared Apr 03, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED
K860998 · JJY
Chemistry · 16d
Cleared Apr 03, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · JJY
Chemistry · 16d

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