510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861304Substantially Equivalent

Fagan Test Machine for Infant Intelligence

Infantest Corp., Shaker Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861304 is the FDA 510(k) clearance record for FAGAN TEST MACHINE FOR INFANT INTELLIGENCE, cleared for Infantest Corp. on under FDA product code LQD (Recorder, Attention Task Performance). FDA records list one 510(k) clearance for Infantest Corp. As of , FDA records show no recalls naming K861304.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LQD Recorder, Attention Task Performance
Device class
Unclassified
Review panel
Unknown
Applicant
Infantest Corp. 2579 N. Moreland,, Shaker Heights OH
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