Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1910144

FEI Number

1910144

Entity Name

CLINICAL REFERENCE LABORATORY, INC.

City/State/Country

Lenexa, KS, US

Establishment Address

8433 Quivira Rd, Lenexa, KS 66215, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Clinical Reference Laboratory (Owner Number: 10038059)

Owner / Operator Contact Address

8433 Quivira Rd, Lenexa, KS 66215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153597

PMA Number

N/A

All Registered Proprietary Names

CRL Collection Kit CRL Stat CRL-Stat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2011-09-09
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2022-12-15
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2022-12-15
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2022-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2022-12-15
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2022-12-15
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2022-12-15
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2022-12-15
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2022-12-15
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2022-12-15
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2022-12-15
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2022-12-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2022-06-09
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2022-06-09
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2022-06-09
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2022-06-09
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2022-06-09
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2022-06-09
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2022-06-09
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2022-06-09
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2022-06-09

Official Correspondent

Rebecca Henkhaus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Clinical Reference Laboratory

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25
K163220	Siemens Healthcare Diagnostics, Inc.	Atellica CH Phencyclidine (Pcp)	2017-04-06
K252550	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18
K202567	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	2020-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1910144. Last updated year: 2026. Please use registration number 1910144 when referencing this establishment in official correspondence.