The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for Kalazar Detect.
| Device ID | K023483 |
| 510k Number | K023483 |
| Device Name: | KALAZAR DETECT |
| Classification | Reagent, Leishmanii Serological |
| 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 | LOO |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-17 |
| Decision Date | 2003-05-06 |