The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for Insure Pregnancy Test.
| Device ID | K991515 |
| 510k Number | K991515 |
| Device Name: | INSURE PREGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Contact | Estela I Raychaudhuri |
| Correspondent | Estela I Raychaudhuri INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-30 |
| Decision Date | 1999-05-28 |