The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for Insure Pro Test.
| Device ID | K992695 |
| 510k Number | K992695 |
| Device Name: | INSURE PRO TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Contact | Estela Raychaudhuri |
| Correspondent | Estela Raychaudhuri INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-11 |
| Decision Date | 1999-10-18 |