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Ciba Corning Diagnostics Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
125
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K962559ACS CORTISOL IMMUNOASSAYNovember 5, 1996
K963251CIBA CORNING ACS;180 DPD ASSAYOctober 15, 1996
K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4July 26, 1996
K961657CIBA CORNING 400 SYSTEMJune 25, 1996
K962021CIBA CORNING 348 SYSTEMJune 24, 1996
K962126ACS CKMB II IMMUNOASSAYJune 21, 1996
K962041ACS LH2 IMMUNOASSAYJune 21, 1996
K961510ACS FRT4 IMMUNOASSAYJune 17, 1996
K960246LIQUID CARDIAC MARKER 1,2,3 ASSAYEDApril 23, 1996
K955873ACS PHENYTOIN ASSAYMarch 11, 1996
K954697CIBA CORNING ACS ESTRADIOL-6 ASSAYDecember 13, 1995
K953021ACS PHENOBARBITALDecember 11, 1995
K953020ACS GENTAMICINAugust 2, 1995
K951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYJune 20, 1995
K951059CIBA CORNING ACS VANCOMYCIN IMMUNOASSAYJune 19, 1995
K951796CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAYJune 13, 1995
K945367CIBA CORNING ACS CORTISOL IMMUNOASSAYMay 5, 1995
K946224CERTAIN(R) ELITE LEVEL 1, 2 AND 3January 30, 1995
K946206CIBA CORNING 8-- SERIES CO-OXIMETERJanuary 30, 1995
K943297CIBA CORNING ACS FOLATE ASSAYDecember 12, 1994