The following data is part of a premarket notification filed by Biomedical Products Corp. with the FDA for One-step Double-chek Pregnancy Test.
| Device ID | K992915 |
| 510k Number | K992915 |
| Device Name: | ONE-STEP DOUBLE-CHEK PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIOMEDICAL PRODUCTS CORP. 15 OAK ST. Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White BIOMEDICAL PRODUCTS CORP. 15 OAK ST. Beverly Farms, MA 01915 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 1999-11-18 |
| Summary: | summary |