|
Document Number | K163704 |
Test Name | Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard |
Manufacturer Name | HEALGEN SCIENTIFIC LLC |
Consumer Information Phone Number | (800)986-2092 |
Test Type | Oxycodone |
Effective Date | 07/11/2019 |
| |
Device Classification Name |
enzyme immunoassay, benzodiazepine
|
510(k) Number |
K163704 |
Device Name |
Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card |
Applicant |
HEALGEN SCIENTIFIC LLC |
5213 Maple St. |
Bellaire,
TX
77401
|
|
Applicant Contact |
Jianqiu Fang |
Correspondent |
LSI International Inc. |
504 East Diamond Ave. |
Suite I |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3170
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/29/2016 |
Decision Date | 08/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
|