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510(k) K951169

CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code LGS

K951169 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 20, 1995. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
March 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

Other clearances by Ciba Corning Diagnostics Corp.

  • K962559 — ACS CORTISOL IMMUNOASSAY (November 5, 1996)
  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (October 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (June 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (April 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)

Other clearances for product code LGS

  • K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (June 8, 2007)
  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
  • K953016 — AXSYM THEOPHYLLINE II (August 24, 1995)
  • K942991 — QMS THEOPHYLLINE CS (September 9, 1994)
  • K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (August 9, 1993)
  • K922991 — ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (August 27, 1992)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (May 28, 1987)
  • K870277 — MONITORX LASERX THEOPHYLLINE REAGENT SET (February 18, 1987)

FDA data resources