Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LCL — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

71 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K011275	PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY	Psychemedics Corp.	2002-02-11	291
K994093	AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C	Phamatech	1999-12-16	13
K913864	PCP DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-10-11	45
K890882	ABUSCREEN FP FOR PHENCYCLIDINE	Roche Diagnostic Systems, Inc.	1989-03-15	22
K882179	EMIT HVA PHENCYCLIDINE ASSAY	Syva Co.	1988-07-12	49
K880011	REVISED LABELING FOR ADX PHENCYCLIDINE	Abbott Laboratories	1988-02-11	38
K874626	REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS	Syva Co.	1988-01-11	62
K874484	REVISED LABELING FOR TDX PHENCYCLIDINE	Abbott Laboratories	1987-11-23	24
K830481	ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE	Hoffmann-La Roche, Inc.	1983-03-24	37
K800514	PHENCYCLIDINE DIRECT BLOOD RIA KIT	Immunalysis Corporation	1980-03-19	14
K790655	ABUSCREEN RIA FOR PHENCYCLIDINE	Hoffmann-La Roche, Inc.	1979-06-15	71

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda