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510(k) K854903

GORDON DIAGNOSTIC SYSTEM MODEL I by Clinical Diagnostics, Inc. — Product Code LQD

K854903 is an FDA 510(k) premarket notification submitted by Clinical Diagnostics, Inc. for the device "GORDON DIAGNOSTIC SYSTEM MODEL I". The FDA issued a decision of Substantially Equivalent on June 2, 1986. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device. Clinical Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1986
Date Received
December 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Attention Task Performance
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Clinical Diagnostics, Inc.

  • K971653 — GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (January 2, 1998)
  • K951457 — GLUCOCHEK POCKETLAB (February 22, 1996)
  • K940215 — GLUCOCHEK (January 17, 1995)
  • K771813 — CENTRIFICHEM SYS 400 ANALYZER (October 25, 1977)
  • K771118 — CENTRIA SEPARATION COLUMNS TYPE A (July 11, 1977)
  • K771117 — CENTRIA CORTISOL RIA (June 23, 1977)
  • K761272 — CENTRIA T4 RIA (March 16, 1977)

Other clearances for product code LQD

  • K173915 — Test of Variables of Attention (T.O.V.A.) (March 22, 2018)
  • K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0 (May 17, 2017)
  • K143468 — QbCheck (March 22, 2016)
  • K141865 — DANA (October 15, 2014)
  • K133382 — QB TEST (March 24, 2014)
  • K122149 — QBTES (October 17, 2012)
  • K040894 — QBTEST (June 22, 2004)
  • K020800 — OPTAX SYSTEM (June 10, 2002)
  • K911938 — DYNAVISION 2000 (August 2, 1991)
  • K861304 — FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (September 23, 1986)

FDA data resources