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510(k) K946224

CERTAIN(R) ELITE LEVEL 1, 2 AND 3 by Ciba Corning Diagnostics Corp. — Product Code JJS

K946224 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CERTAIN(R) ELITE LEVEL 1, 2 AND 3". The FDA issued a decision of Substantially Equivalent on January 30, 1995. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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 JJS

  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002866 — LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (September 25, 2000)

FDA data resources