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510(k) K961807

CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 by Ciba Corning Diagnostics Corp. — Product Code GLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1996
Date Received
May 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hematocrit
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
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)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K962126 — ACS CKMB II 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)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (December 13, 1995)

Other clearances for product code GLK

  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K021924 — MEDICA EASYQC HEMATOCRIT CONTROL (June 24, 2002)
  • K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (May 14, 2002)
  • K964452 — HEMATACHEK (February 20, 1997)
  • K924926 — MSI-HCT (January 7, 1993)
  • K893562 — A.QC HCT LEVEL 1 AND 2 (July 14, 1989)