The following data is part of a premarket notification filed by Newscen Coast Bio-pharmaceutical Co., Ltd with the FDA for Home Pregnancy Test.
| Device ID | K112315 |
| 510k Number | K112315 |
| Device Name: | HOME PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD 2117 CLANEY CT Simi Valley, CA 93065 |
| Contact | Chandravadan Patel |
| Correspondent | Chandravadan Patel NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD 2117 CLANEY CT Simi Valley, CA 93065 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2012-04-23 |
| Summary: | summary |