510(k) K141341
- Device
- CL DETECT RAPID TEST
- Applicant
- INBIOS INTERNATIONAL INC.
- 510(k) number
- K141341
- Product code
- PIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-14
- Date received
- 2014-05-21
- Regulation
- 866.3870
- Classification name
- Leishmania Spp. Antigen Detection Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ESTELA RAYCHAUDHURI
- Address
- 562 1st Ave. S, Suite 600 Seattle WA US 98104 98104
FDA Registration Numbers#
- 3005360469
- 3032562
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary