510(k) K190397

Device: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Applicant: Immunalysis Corporation
510(k) number: K190397
Product code: QBK
Decision: Substantially Equivalent (SESE)
Decision date: 2019-11-15
Date received: 2019-02-19
Regulation: 862.3590
Classification name: Meprobamate Test System
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Yang Yang
Address: 829 Towne Center Dr. Pomona CA US 91767 91767

FDA Registration Numbers#

2020952
3003610499
3005360469
1827821

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840937110294	Immunalysis	IMMUNALYSIS CORP	2017-09-07
00840937110287	Immunalysis	IMMUNALYSIS CORP	2017-09-07
00840937110270	Immunalysis	IMMUNALYSIS CORP	2017-09-07
00840937110263	Immunalysis	IMMUNALYSIS CORP	2017-09-07

Other 510(k) Records For Product Code QBK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN170010	LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay	Lin-Zhi International, Inc.	2018-04-20

Legacy Summary#

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FDA Review#

Decision Summary