|
Document Number | K151642 |
Test Name | Germaine Laboratories, Inc., AimScreen Multi-Drug Urine Test Dip Device CLIA Waived |
Manufacturer Name | HEALGEN SCIENTIFIC LLC |
Consumer Information Phone Number | 1(866)982-3818 |
Test Type | Phencyclidine (PCP) |
Effective Date | 02/22/2016 |
| |
Device Classification Name |
Enzyme Immunoassay, Benzodiazepine
|
510(k) Number |
K151642 |
Device Name |
Heagen 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 | 06/18/2015 |
Decision Date | 08/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
|