The following data is part of a premarket notification filed by Blue Cross Bio-medical Co., Ltd. with the FDA for One Step Hcg Urine Pregnancy Test (strip), Model B01-s, One Step Hcg Urine Pregnancy Test (cassette) , Model B01c.
| Device ID | K071930 |
| 510k Number | K071930 |
| Device Name: | ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BLUE CROSS BIO-MEDICAL CO., LTD. BEIQIJA INDUSTRY ZONE CHANGPING DISTRICT Beijing, CN 102209 |
| Contact | Hilda Hong Yang |
| Correspondent | Hilda Hong Yang BLUE CROSS BIO-MEDICAL CO., LTD. BEIQIJA INDUSTRY ZONE CHANGPING DISTRICT Beijing, CN 102209 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2007-12-18 |