510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854903Substantially Equivalent

Gordon Diagnostic System Model I

Clinical Diagnostics, Inc., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854903 is the FDA 510(k) clearance record for GORDON DIAGNOSTIC SYSTEM MODEL I, cleared for Clinical Diagnostics, Inc. on under FDA product code LQD (Recorder, Attention Task Performance). FDA records list 8 510(k) clearances for Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K854903.

Clearance record

Decision date
Received
(175 days to decision)
Product code
LQD Recorder, Attention Task Performance
Device class
Unclassified
Review panel
Unknown
Applicant
Clinical Diagnostics, Inc. 300 E. Mineral Ave., #6, Littleton CO
Third party review
No

Clearances, product code LQD

Trailing 12 months

FDA records hold no clearances under product code LQD in the trailing twelve months.

FDA records show no clearances under product code LQD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260