|
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| Document Number | K192843 |
| Test Name | Innovita (Tangshan) Biological Technology Co., Ltd. INNOVITA HCG Pregnancy Rapid Test Cassette |
| Manufacturer Name | Innovita (Tangshan) Biological Technology Co., Ltd. |
| Consumer Information Phone Number | USA(800)710-9838 |
| Test Type | hCG, Urine |
| Effective Date | 11/29/2019 |
| |
| Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
|
|---|
| 510(k) Number |
K192843 |
|---|
| Device Name |
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream |
|---|
| Applicant |
| Innovita (Tangshan) Biological Technology Co., Ltd. |
| # 699 Juxin St., High-Tech Industrial Development Zone |
|
Qian'An,
CN
064400
|
|
| Applicant Contact |
Leo Lee |
| Correspondent |
| Huajian US Services |
| 19800 Macarthur Blvd., Suite 420 |
|
Irvine,
CA
92612
|
|
| Correspondent Contact |
Fiona Wang |
| Regulation Number | 862.1155 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/03/2019 |
|---|
| Decision Date | 11/22/2019 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
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|
