K141341 is an FDA 510(k) clearance for the CL DETECT RAPID TEST. This device is classified as a Leishmania Spp. Antigen Detection Assay (Class I - General Controls, product code PIT).
Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on November 14, 2014, 177 days after receiving the submission on May 21, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3870. An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection..
| 510(k) Number | K141341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2014 |
| Decision Date | November 14, 2014 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | PIT — Leishmania Spp. Antigen Detection Assay |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3870 |
| Definition | An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection. |