510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935629Substantially Equivalent

Usdt Phencyclidine (Pcp) Assay Column Cat. No. 9000-400

U.S. Drug Testing, Inc., Rancho Cucamonga CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935629 is the FDA 510(k) clearance record for USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400, cleared for U.S. Drug Testing, Inc. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 6 510(k) clearances for U.S. Drug Testing, Inc., from to . As of , FDA records show no recalls naming K935629.

Clearance record

Decision date
Received
(140 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
U.S. Drug Testing, Inc. 10410 Trademark St., Rancho Cucamonga CA
510(k) summary
Statement
Third party review
No

Clearances, product code LCM

Trailing 12 months

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

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