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
51-75 of 100
Cleared Sep 27, 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · CHL
Chemistry · 15d
Cleared Sep 10, 1990
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861 · DON
Chemistry · 74d
Cleared Jul 17, 1990
LVM QUALITY CONTROL SERUM
K902235 · JJY
Chemistry · 61d
Cleared Jun 28, 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · CEP
Chemistry · 29d
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336 · JJE
Chemistry · 25d
Cleared May 01, 1990
LIG/TDM A, B, C
K901212 · JJY
Chemistry · 48d
Cleared Oct 30, 1989
CIBA CORNING CERTAIN LYTE
K894576 · JJR
Chemistry · 101d
Cleared Oct 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · CFT
Chemistry · 65d
Cleared Sep 28, 1989
KIT- CIBA CORNING L-TDM I, II, III
K893682 · DIF
Chemistry · 135d
Cleared Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · JQP
Chemistry · 99d
Cleared Jul 27, 1989
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · CGN
Chemistry · 72d
Cleared Jul 25, 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · DIF
Chemistry · 62d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · JGS
Chemistry · 98d
Cleared Feb 17, 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · CIN
Chemistry · 74d
Cleared Jan 17, 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · CEM
Chemistry · 64d
Cleared Dec 06, 1988
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · CGJ
Chemistry · 28d
Cleared Nov 10, 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · JKA
Chemistry · 63d
Cleared Nov 04, 1988
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722 · CDD
Chemistry · 65d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · CEW
Chemistry · 114d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · JHI
Chemistry · 28d
Cleared Jul 08, 1988
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · DON
Chemistry · 80d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · GKR
Chemistry · 141d
Cleared Mar 03, 1988
CIBA CORNING MODEL 644
K875098 · JXR
Chemistry · 84d
Cleared Jan 21, 1988
TRIGLYERIDES TEST KIT
K874584 · CDT
Chemistry · 73d
Cleared Dec 18, 1987
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603 · KLI
Chemistry · 39d

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