Device Classification Name |
blood, occult, colorimetric, in urine
|
510(k) Number |
K111999 |
Device Name |
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL |
Applicant |
HEALGEN SCIENTIFIC, LLC |
5213 MAPLE STREET |
BELLAIRE,
TX
77401
|
|
Applicant Contact |
YONGQUAN WANG |
Correspondent |
HEALGEN SCIENTIFIC, LLC |
5213 MAPLE STREET |
BELLAIRE,
TX
77401
|
|
Correspondent Contact |
YONGQUAN WANG |
Regulation Number | 864.6550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/13/2011 |
Decision Date | 04/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|