Device Classification Name |
visual, pregnancy hcg, prescription use
|
510(k) Number |
K152768 |
Device Name |
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip |
Applicant |
ASSURE TECH. CO., LTD. |
2ND. FLOOR, BUILDING 1, NO. 10, XIYUANSAN ROAD, |
HANGZHOU,
CN
310030
|
|
Applicant Contact |
ERIC LIN |
Correspondent |
LSI INTERNATIONAL |
504 E DIAMOND AVE., SUITE I |
GAITHERSBURG,
MD
20877
|
|
Correspondent Contact |
JOE SHIA |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 09/24/2015 |
Decision Date | 02/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|