510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991465Substantially Equivalent

Drug Stop

Texas Immunology, Inc., Tyler TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991465 is the FDA 510(k) clearance record for DRUG STOP, cleared for Texas Immunology, Inc. on under FDA product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter). FDA records list 27 510(k) clearances for Texas Immunology, Inc., from to . As of , FDA records show no recalls naming K991465.

Clearance record

Decision date
Received
(227 days to decision)
Product code
MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device class
Unclassified
Review panel
Unknown
Applicant
Texas Immunology, Inc. 12524 Fm3226, Tyler TX
510(k) summary
Statement
Third party review
No

Clearances, product code MVO

Trailing 12 months

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

FDA records show no clearances under product code MVO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MVO, 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