The following data is part of a premarket notification filed by Bioscreen Medical Inc. with the FDA for One Step Hcg Pregnancy Urine Test Formats: Strip, Cassette And Midstream, Models Bm-1-1, Bm-1-2, Bm-1-3, Bm-2-1, Bm-2-2.
| Device ID | K050305 |
| 510k Number | K050305 |
| Device Name: | ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIOSCREEN MEDICAL INC. RR I BOX 1045A Mildred, PA 18632 |
| Contact | Jimmy Liang |
| Correspondent | Jimmy Liang BIOSCREEN MEDICAL INC. RR I BOX 1045A Mildred, PA 18632 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-08 |
| Decision Date | 2005-05-23 |