510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203489Substantially Equivalent

SEFRIA PCP Oral Fluid Enzyme Immunoassay

Immunalysis Corporation, Pomona CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203489 is the FDA 510(k) clearance record for SEFRIA PCP Oral Fluid Enzyme Immunoassay, cleared for Immunalysis Corporation on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 50 510(k) clearances for Immunalysis Corporation, from to . As of , FDA records show no recalls naming K203489.

Clearance record

Decision date
Received
(144 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Immunalysis Corporation 829 Towne Center Dr., Pomona CA
510(k) summary
Summary PDF
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