The following data is part of a premarket notification filed by Inbios International Inc. with the FDA for Cl Detect Rapid Test.
| Device ID | K141341 |
| 510k Number | K141341 |
| Device Name: | CL DETECT RAPID TEST |
| Classification | Leishmania Spp. Antigen Detection Assay |
| Applicant | INBIOS INTERNATIONAL INC. 562 1ST AVE S STE 600 Seattle, WA 98104 |
| Contact | Estela Raychaudhuri |
| Correspondent | Estela Raychaudhuri INBIOS INTERNATIONAL INC. 562 1ST AVE S STE 600 Seattle, WA 98104 |
| Product Code | PIT |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-11-14 |