Device Classification Name |
Visual, Pregnancy Hcg, Prescription Use
|
510(k) Number |
K172257 |
Device Name |
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) |
Applicant |
True Diagnostics, Inc |
2782 Loker Ave West |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Jerry Lee |
Correspondent |
Biologics Consulting Group |
1555 King St., Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Jinjie Hu |
Regulation Number | 862.1155
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2017 |
Decision Date | 12/22/2017 |
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
|
|
|