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510(k) K915332

MODEL 795 FLUOROMETER/DENSITOMETER by Ciba Corning Diagnostics Corp. — Product Code JQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type

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  • 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 JQT

  • K111356 — ASIMANAGER - AT (November 9, 2011)
  • K944185 — ISOSCAN (November 17, 1994)
  • K885254 — TARGET READER (January 27, 1989)
  • K860645 — ELECTROPHORESIS DATA CENTER (EDC) (December 17, 1986)
  • K862956 — ICON READER (August 19, 1986)
  • K853734 — APOLLO DENSITOMETER (September 25, 1985)
  • K851154 — ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (May 13, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K850260 — GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (February 27, 1985)
  • K842313 — ELVI 146 SEROSCAN (September 10, 1984)