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Document Number | K153597 |
Test Name | Germaine Laboratories, Inc., AimScreen Multi-Drug Urine Test DipDevice |
Manufacturer Name | HEALGEN SCIENTIFIC LLC |
Consumer Information Phone Number | (800)854-8446 |
Test Type | Amphetamines |
Effective Date | 07/28/2016 |
| |
Device Classification Name |
Enzyme Immunoassay, Benzodiazepine
|
510(k) Number |
K153597 |
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 XIA |
Regulation Number | 862.3170
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/16/2015 |
Decision Date | 05/23/2016 |
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
|
|
|
|