510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800514Substantially Equivalent

Phencyclidine Direct Blood Ria Kit

Immunalysis Corporation, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800514 is the FDA 510(k) clearance record for PHENCYCLIDINE DIRECT BLOOD RIA KIT, cleared for Immunalysis Corporation on under FDA product code LCL (Radioimmunoassay, Phencyclidine). FDA records list 50 510(k) clearances for Immunalysis Corporation, from to . As of , FDA records show no recalls naming K800514.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LCL Radioimmunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Immunalysis Corporation 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LCL

Trailing 12 months

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

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