510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K043071Substantially Equivalent

Randox Phencyclidine Assay

Randox Laboratories, Limited, Crumlin, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043071 is the FDA 510(k) clearance record for RANDOX PHENCYCLIDINE ASSAY, cleared for Randox Laboratories, Ltd. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show no recalls naming K043071.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Randox Laboratories, Ltd. 55 Diamond Rd., Crumlin, GB
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260